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Testare l'aggiunta del farmaco antitumorale Sonrotoclax al trattamento standard Zanubrutinib, per CLL/SLL precedentemente non trattata

2 novembre 2026 aggiornato da: Alliance for Clinical Trials in Oncology

Valutazione di Fase III della Terapia a Durata Fissa a Base di Zanubrutinib più Sonrotoclax Confrontata con Zanubrutinib Continuo in Pazienti Anziani con Leucemia Linfatica Cronica/Linfoma Linfocitico a Piccole Cellule (CLL/SLL) Non Precedentemente Trattati

This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. To compare the progression free survival (PFS) between minimal residual disease (MRD)-guided zanubrutinib sonrotoclax therapy to continuous zanubrutinib as control.

II. To determine the PFS comparing fixed duration zanubrutinib sonrotoclax therapy to continuous zanubrutinib as control.

SECONDARY OBJECTIVES:

I. To compare the PFS between the patients with MRD-detectable disease treated with fixed duration zanubrutinib sonrotoclax to the PFS of the patients with MRD detectable disease who receive one additional year of combination therapy.

II. To determine the overall survival of all arms of the study. III. To determine the frequency of patients with MRD-detectable disease who convert to undetectable MRD, and at what depth and for how long, after receiving an extra year of combination therapy on the MRD-guided zanubrutinib sonrotoclax therapy arm.

IV. To determine and compare the overall response rate (ORR defined as PR, CR, CCR, CRi) and complete remission rate (CR) after 14 cycles of therapy among the three arms.

V. To compare time to the next CLL/SLL therapy among treatment arms. VI. To determine the rates and severity of toxicity in each arm, with a particular focus on adverse events of special interest that include infections, cardiovascular events (arrhythmias, heart failure, hypertension), tumor lysis syndrome, bleeding events, cytopenias, and second malignancies.

VII. To compare patient-reported symptomatic adverse events as assessed by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) between arms 1 and 2.

EXPLORATORY OBJECTIVES:

I. To compare the best achieved rate of undetectable MRD (uMRD) between the fixed duration zanubrutinib sonrotoclax arm and the MRD guided zanubrutinib sonrotoclax arm.

II. To compare rates of undetectable MRD measured by the immunoglobulin heavy chain (IGH) sequencing assay ClonoSeq (sensitivity 1 in 10^-6) to undetectable MRD measured by standard six-color flow cytometry (uMRD4), and to compare results from bone marrow to peripheral blood.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with at least partial remission continue therapy as described above. Patients with progressive disease proceed to follow up. Patients undergo computed tomography (CT) scan, bone marrow aspiration and blood sample collection throughout the study.

ARM 2: Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Starting cycle 4 day 1 patients also receive sonrotoclax PO daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with undetectable MRD and a response of PR, partial response with persistent lymphocytosis (PR-L), CR, CCR or CRi stop therapy at cycle 15 day 28 and proceed to follow up. Patients with detectable MRD and an objective response to therapy are re-randomized to arm 2B or arm 2C.

ARM 2B: Patients continue zanubrutinib PO BID sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for an additonal 12 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2C: Patients discontinue therapy starting at cycle 15 day 28 and proceed to follow up.

Patients undergo CT scan, bone marrow aspiration and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 3 years then every 6 months until 10 years for study registration. Patients with progression or the start of non protocol CLL directed therapy are followed every 6 months for 10 years from registration.

Tipo di studio

Interventistico

Iscrizione (Stimato)

466

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Reclutamento
        • University of Alabama at Birmingham Cancer Center
        • Contatto:
        • Investigatore principale:
          • Firas Baidoun
    • California
      • Anaheim, California, Stati Uniti, 92806
        • Reclutamento
        • Kaiser Permanente-Anaheim
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Baldwin Park, California, Stati Uniti, 91706
        • Reclutamento
        • Kaiser Permanente-Baldwin Park
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Bellflower, California, Stati Uniti, 90706
        • Reclutamento
        • Kaiser Permanente-Bellflower
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Dublin, California, Stati Uniti, 94568
        • Reclutamento
        • Kaiser Permanente Dublin
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
        • Investigatore principale:
          • Faisal N. Cheema
      • Fontana, California, Stati Uniti, 92335
        • Reclutamento
        • Kaiser Permanente-Fontana
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Fremont, California, Stati Uniti, 94538
        • Reclutamento
        • Kaiser Permanente-Fremont
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Fresno, California, Stati Uniti, 93720
        • Reclutamento
        • Kaiser Permanente Fresno Orchard Plaza
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 833-574-2273
        • Investigatore principale:
          • Faisal N. Cheema
      • Harbor City, California, Stati Uniti, 90710
        • Reclutamento
        • Kaiser Permanente South Bay
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Irvine, California, Stati Uniti, 92618
        • Reclutamento
        • Kaiser Permanente-Irvine
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Los Angeles, California, Stati Uniti, 90048
        • Reclutamento
        • Cedars-Sinai Medical Center
        • Investigatore principale:
          • Justin M. Darrah
        • Contatto:
      • Los Angeles, California, Stati Uniti, 90027
        • Reclutamento
        • Kaiser Permanente Los Angeles Medical Center
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Los Angeles, California, Stati Uniti, 90034
        • Reclutamento
        • Kaiser Permanente West Los Angeles
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Modesto, California, Stati Uniti, 95356
        • Reclutamento
        • Kaiser Permanente- Modesto MOB II
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
        • Investigatore principale:
          • Faisal N. Cheema
      • Oakland, California, Stati Uniti, 94611
        • Reclutamento
        • Kaiser Permanente-Oakland
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Ontario, California, Stati Uniti, 91761
        • Reclutamento
        • Kaiser Permanente-Ontario
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Panorama City, California, Stati Uniti, 91402
        • Reclutamento
        • Kaiser Permanente - Panorama City
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Riverside, California, Stati Uniti, 92505
        • Reclutamento
        • Kaiser Permanente-Riverside
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • Roseville, California, Stati Uniti, 95661
        • Reclutamento
        • Kaiser Permanente-Roseville
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Sacramento, California, Stati Uniti, 95814
        • Reclutamento
        • Kaiser Permanente Downtown Commons
        • Investigatore principale:
          • Faisal N. Cheema
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: kpoct@kp.org
      • Sacramento, California, Stati Uniti, 95823
        • Reclutamento
        • Kaiser Permanente-South Sacramento
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Diego, California, Stati Uniti, 92120
        • Reclutamento
        • Kaiser Permanente-San Diego Zion
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • San Francisco, California, Stati Uniti, 94115
        • Reclutamento
        • Kaiser Permanente-San Francisco
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Jose, California, Stati Uniti, 95119
        • Reclutamento
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Leandro, California, Stati Uniti, 94577
        • Reclutamento
        • Kaiser Permanente San Leandro
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Marcos, California, Stati Uniti, 92078
        • Reclutamento
        • Kaiser Permanente-San Marcos
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
      • San Rafael, California, Stati Uniti, 94903
        • Reclutamento
        • Kaiser San Rafael-Gallinas
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Santa Clara, California, Stati Uniti, 95051
        • Reclutamento
        • Kaiser Permanente Medical Center - Santa Clara
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Santa Rosa, California, Stati Uniti, 95403
        • Reclutamento
        • Kaiser Permanente-Santa Rosa
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • South San Francisco, California, Stati Uniti, 94080
        • Reclutamento
        • Kaiser Permanente-South San Francisco
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Vallejo, California, Stati Uniti, 94589
        • Reclutamento
        • Kaiser Permanente-Vallejo
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Walnut Creek, California, Stati Uniti, 94596
        • Reclutamento
        • Kaiser Permanente-Walnut Creek
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Woodland Hills, California, Stati Uniti, 91367
        • Reclutamento
        • Kaiser Permanente-Woodland Hills
        • Investigatore principale:
          • Ashraf R. Aziz
        • Contatto:
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80909
        • Reclutamento
        • UCHealth Memorial Hospital Central
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 719-365-2406
        • Investigatore principale:
          • Shin Yin Lee
      • Colorado Springs, Colorado, Stati Uniti, 80920
        • Reclutamento
        • Memorial Hospital North
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 719-364-6700
        • Investigatore principale:
          • Shin Yin Lee
      • Denver, Colorado, Stati Uniti, 80205
        • Reclutamento
        • Kaiser Permanente-Franklin
        • Investigatore principale:
          • Matthew J. Eadens
        • Contatto:
      • Grand Junction, Colorado, Stati Uniti, 81505
        • Reclutamento
        • Grand Valley Oncology
        • Contatto:
        • Investigatore principale:
          • Jonathan D. King
      • Lafayette, Colorado, Stati Uniti, 80026
        • Reclutamento
        • Kaiser Permanente-Rock Creek
        • Investigatore principale:
          • Matthew J. Eadens
        • Contatto:
      • Lone Tree, Colorado, Stati Uniti, 80124
        • Reclutamento
        • Kaiser Permanente-Lone Tree
        • Investigatore principale:
          • Matthew J. Eadens
        • Contatto:
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Reclutamento
        • Helen F Graham Cancer Center
        • Investigatore principale:
          • Gregory A. Masters
        • Contatto:
      • Newark, Delaware, Stati Uniti, 19713
        • Reclutamento
        • Medical Oncology Hematology Consultants PA
        • Investigatore principale:
          • Gregory A. Masters
        • Contatto:
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33146
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Coral Springs, Florida, Stati Uniti, 33065
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Deerfield Beach, Florida, Stati Uniti, 33442
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Doral, Florida, Stati Uniti, 33166
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Contatto:
        • Investigatore principale:
          • Georgios Pongas
      • Hollywood, Florida, Stati Uniti, 33021
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Jupiter, Florida, Stati Uniti, 33458
        • Reclutamento
        • Jupiter Medical Center
        • Investigatore principale:
          • Ryan H. Devine
        • Contatto:
      • Lakeland, Florida, Stati Uniti, 33805
        • Reclutamento
        • The Watson Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 863-680-7780
        • Investigatore principale:
          • Leonard J. Gitter
      • Miami, Florida, Stati Uniti, 33136
        • Reclutamento
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Miami, Florida, Stati Uniti, 33176
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
      • Miami Beach, Florida, Stati Uniti, 33140
        • Reclutamento
        • Mount Sinai Medical Center
        • Contatto:
        • Investigatore principale:
          • Jacqueline C. Barrientos
      • North Miami, Florida, Stati Uniti, 33181
        • Reclutamento
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Contatto:
        • Investigatore principale:
          • Georgios Pongas
      • Plantation, Florida, Stati Uniti, 33324
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Georgios Pongas
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96819
        • Reclutamento
        • Kaiser Permanente Moanalua Medical Center
        • Contatto:
        • Investigatore principale:
          • Faisal N. Cheema
    • Idaho
      • Boise, Idaho, Stati Uniti, 83706
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Boise
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Caldwell, Idaho, Stati Uniti, 83605
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, Stati Uniti, 83814
        • Reclutamento
        • Kootenai Health - Coeur d'Alene
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Meridian, Idaho, Stati Uniti, 83642
        • Reclutamento
        • Idaho Urologic Institute-Meridian
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Post Falls, Idaho, Stati Uniti, 83854
        • Reclutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Reclutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Illinois
      • Bloomington, Illinois, Stati Uniti, 61704
        • Reclutamento
        • Illinois CancerCare-Bloomington
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Canton, Illinois, Stati Uniti, 61520
        • Reclutamento
        • Illinois CancerCare-Canton
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Carthage, Illinois, Stati Uniti, 62321
        • Reclutamento
        • Illinois CancerCare-Carthage
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern University
        • Contatto:
        • Investigatore principale:
          • Shuo Ma
      • Chicago, Illinois, Stati Uniti, 60612
        • Reclutamento
        • University of Illinois
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-355-3046
        • Investigatore principale:
          • Carlos Galvez
      • Danville, Illinois, Stati Uniti, 61832
        • Reclutamento
        • Carle at The Riverfront
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Cancer Care Specialists of Illinois - Decatur
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Decatur Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Dixon, Illinois, Stati Uniti, 61021
        • Reclutamento
        • Illinois CancerCare-Dixon
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 815-285-7800
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Carle Physician Group-Effingham
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Eureka, Illinois, Stati Uniti, 61530
        • Reclutamento
        • Illinois CancerCare-Eureka
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Galesburg, Illinois, Stati Uniti, 61401
        • Reclutamento
        • Illinois CancerCare-Galesburg
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Kewanee, Illinois, Stati Uniti, 61443
        • Reclutamento
        • Illinois CancerCare-Kewanee Clinic
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Macomb, Illinois, Stati Uniti, 61455
        • Reclutamento
        • Illinois CancerCare-Macomb
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Mattoon, Illinois, Stati Uniti, 61938
        • Reclutamento
        • Carle Physician Group-Mattoon/Charleston
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle BroMenn Medical Center
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle Cancer Institute Normal
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Cancer Care Center of O'Fallon
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Reclutamento
        • HSHS Saint Elizabeth's Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Ottawa, Illinois, Stati Uniti, 61350
        • Reclutamento
        • Illinois CancerCare-Ottawa Clinic
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Pekin, Illinois, Stati Uniti, 61554
        • Reclutamento
        • Illinois CancerCare-Pekin
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Peoria, Illinois, Stati Uniti, 61615
        • Reclutamento
        • Illinois CancerCare-Peoria
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Peru, Illinois, Stati Uniti, 61354
        • Reclutamento
        • Illinois CancerCare-Peru
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Princeton, Illinois, Stati Uniti, 61356
        • Reclutamento
        • Illinois CancerCare-Princeton
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
      • Rockford, Illinois, Stati Uniti, 61114
        • Reclutamento
        • UW Health Carbone Cancer Center Rockford
        • Contatto:
        • Investigatore principale:
          • Fahrettin Covut
      • Shiloh, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Memorial Hospital East
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Southern Illinois University School of Medicine
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 217-545-7929
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Springfield Clinic
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-444-7541
      • Springfield, Illinois, Stati Uniti, 62781
        • Reclutamento
        • Springfield Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Urbana, Illinois, Stati Uniti, 61801
        • Reclutamento
        • Carle Cancer Center
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Washington, Illinois, Stati Uniti, 61571
        • Reclutamento
        • Illinois CancerCare - Washington
        • Contatto:
        • Investigatore principale:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, Stati Uniti, 50010
        • Reclutamento
        • Mary Greeley Medical Center
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Ames, Iowa, Stati Uniti, 50010
        • Reclutamento
        • McFarland Clinic - Ames
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
      • Ankeny, Iowa, Stati Uniti, 50023
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Carroll, Iowa, Stati Uniti, 51401
        • Reclutamento
        • Saint Anthony Regional Hospital
        • Contatto:
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, Stati Uniti, 52403
        • Reclutamento
        • Mercy Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 319-365-4673
        • Investigatore principale:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Stati Uniti, 52403
        • Reclutamento
        • Oncology Associates at Mercy Medical Center
        • Investigatore principale:
          • Deborah W. Wilbur
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 319-363-2690
      • Clive, Iowa, Stati Uniti, 50325
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • Broadlawns Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-282-2200
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • Mercy Medical Center - Des Moines
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Richard L. Deming
      • Des Moines, Iowa, Stati Uniti, 50309
        • Reclutamento
        • Iowa Methodist Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-6727
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50309
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Stati Uniti, 50501
        • Reclutamento
        • McFarland Clinic - Trinity Cancer Center
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Fort Dodge, Iowa, Stati Uniti, 50501
        • Reclutamento
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Investigatore principale:
          • Seema Harichand-Herdt
        • Contatto:
      • Marshalltown, Iowa, Stati Uniti, 50158
        • Reclutamento
        • McFarland Clinic - Marshalltown
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Pella, Iowa, Stati Uniti, 50219
        • Reclutamento
        • UI Healthcare Mission Cancer and Blood - Pella
        • Investigatore principale:
          • Seema Harichand-Herdt
        • Contatto:
      • Waukee, Iowa, Stati Uniti, 50263
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
    • Kansas
      • Chanute, Kansas, Stati Uniti, 66720
        • Reclutamento
        • Cancer Center of Kansas - Chanute
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Dodge City, Kansas, Stati Uniti, 67801
        • Reclutamento
        • Cancer Center of Kansas - Dodge City
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • El Dorado, Kansas, Stati Uniti, 67042
        • Reclutamento
        • Cancer Center of Kansas - El Dorado
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Hays, Kansas, Stati Uniti, 67601
        • Reclutamento
        • HaysMed
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 785-623-5774
      • Independence, Kansas, Stati Uniti, 67301
        • Reclutamento
        • Cancer Center of Kansas-Independence
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Kansas City, Kansas, Stati Uniti, 66160
        • Reclutamento
        • University of Kansas Cancer Center
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Kingman, Kansas, Stati Uniti, 67068
        • Reclutamento
        • Cancer Center of Kansas-Kingman
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Lawrence, Kansas, Stati Uniti, 66044
        • Reclutamento
        • Lawrence Memorial Hospital
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Liberal, Kansas, Stati Uniti, 67905
        • Reclutamento
        • Cancer Center of Kansas-Liberal
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • McPherson, Kansas, Stati Uniti, 67460
        • Reclutamento
        • Cancer Center of Kansas - McPherson
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Newton, Kansas, Stati Uniti, 67114
        • Reclutamento
        • Cancer Center of Kansas - Newton
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Olathe, Kansas, Stati Uniti, 66061
        • Reclutamento
        • The University of Kansas Cancer Center - Olathe
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Overland Park, Kansas, Stati Uniti, 66210
        • Reclutamento
        • University of Kansas Cancer Center-Overland Park
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Parsons, Kansas, Stati Uniti, 67357
        • Reclutamento
        • Cancer Center of Kansas - Parsons
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Pratt, Kansas, Stati Uniti, 67124
        • Reclutamento
        • Cancer Center of Kansas - Pratt
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Salina, Kansas, Stati Uniti, 67401
        • Reclutamento
        • Cancer Center of Kansas - Salina
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Salina, Kansas, Stati Uniti, 67401
        • Reclutamento
        • Salina Regional Health Center
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Topeka, Kansas, Stati Uniti, 66606
        • Reclutamento
        • University of Kansas Health System Saint Francis Campus
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 785-295-8000
      • Wellington, Kansas, Stati Uniti, 67152
        • Reclutamento
        • Cancer Center of Kansas - Wellington
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Westwood, Kansas, Stati Uniti, 66205
        • Reclutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Wichita, Kansas, Stati Uniti, 67208
        • Reclutamento
        • Cancer Center of Kansas-Wichita Medical Arts Tower
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Wichita, Kansas, Stati Uniti, 67214
        • Reclutamento
        • Ascension Via Christi Hospitals Wichita
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Wichita, Kansas, Stati Uniti, 67214
        • Reclutamento
        • Cancer Center of Kansas - Wichita
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
      • Winfield, Kansas, Stati Uniti, 67156
        • Reclutamento
        • Cancer Center of Kansas - Winfield
        • Contatto:
        • Investigatore principale:
          • Dennis F. Moore
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • The James Graham Brown Cancer Center at University of Louisville
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 502-562-3429
        • Investigatore principale:
          • Hassaan Yasin
      • Louisville, Kentucky, Stati Uniti, 40245
        • Reclutamento
        • UofL Health Medical Center Northeast
        • Contatto:
        • Investigatore principale:
          • Hassaan Yasin
    • Louisiana
      • Monroe, Louisiana, Stati Uniti, 71202
        • Reclutamento
        • Ochsner LSU Health Monroe Medical Center
        • Contatto:
        • Investigatore principale:
          • Shiva Jashwanth Gaddam
      • Shreveport, Louisiana, Stati Uniti, 71103
        • Reclutamento
        • LSU Health Sciences Center at Shreveport
        • Contatto:
        • Investigatore principale:
          • Shiva Jashwanth Gaddam
    • Maine
      • Portland, Maine, Stati Uniti, 04102
        • Reclutamento
        • MaineHealth Maine Medical Center - Portland
        • Contatto:
        • Investigatore principale:
          • Andrew Rogers
      • South Portland, Maine, Stati Uniti, 04106
        • Reclutamento
        • MaineHealth Cancer Care and IV Therapy - South Portland
        • Contatto:
        • Investigatore principale:
          • Andrew Rogers
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana-Farber Cancer Institute
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-442-3324
        • Investigatore principale:
          • Jennifer R. Brown
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Beth Israel Deaconess Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 617-667-9925
        • Investigatore principale:
          • Jon E. Arnason
    • Michigan
      • Brighton, Michigan, Stati Uniti, 48114
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Canton, Michigan, Stati Uniti, 48188
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Stati Uniti, 48118
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Detroit, Michigan, Stati Uniti, 48201
        • Reclutamento
        • Wayne State University/Karmanos Cancer Institute
        • Investigatore principale:
          • Jay Yang
        • Contatto:
      • Farmington Hills, Michigan, Stati Uniti, 48334
        • Reclutamento
        • Weisberg Cancer Treatment Center
        • Investigatore principale:
          • Jay Yang
        • Contatto:
      • Lansing, Michigan, Stati Uniti, 48912
        • Reclutamento
        • University of Michigan Health - Sparrow Lansing
        • Investigatore principale:
          • Christopher M. Reynolds
        • Contatto:
      • Livonia, Michigan, Stati Uniti, 48154
        • Reclutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Stati Uniti, 48341
        • Reclutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
    • Minnesota
      • Bemidji, Minnesota, Stati Uniti, 56601
      • Brainerd, Minnesota, Stati Uniti, 56401
        • Reclutamento
        • Essentia Health Saint Joseph's Medical Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Burnsville, Minnesota, Stati Uniti, 55337
        • Reclutamento
        • Minnesota Oncology - Burnsville
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Reclutamento
        • Mercy Hospital
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Deer River, Minnesota, Stati Uniti, 56636
        • Reclutamento
        • Essentia Health - Deer River Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Duluth, Minnesota, Stati Uniti, 55805
        • Reclutamento
        • Essentia Health Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Minnesota Oncology - Edina
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Hibbing, Minnesota, Stati Uniti, 55746
        • Reclutamento
        • Essentia Health Hibbing Clinic
        • Investigatore principale:
          • Bret E. Friday
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 218-786-3308
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Reclutamento
        • Abbott-Northwestern Hospital
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Mayo Clinic in Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
        • Investigatore principale:
          • Sameer A. Parikh
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • Reclutamento
        • United Hospital
        • Contatto:
        • Investigatore principale:
          • Yan Ji
      • Sandstone, Minnesota, Stati Uniti, 55072
        • Reclutamento
        • Essentia Health Sandstone
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Virginia, Minnesota, Stati Uniti, 55792
        • Reclutamento
        • Essentia Health Virginia Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Woodbury, Minnesota, Stati Uniti, 55125
        • Reclutamento
        • Fairview Cancer Center - Woodbury
        • Investigatore principale:
          • Yan Ji
        • Contatto:
    • Mississippi
      • Southhaven, Mississippi, Stati Uniti, 38671
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
    • Missouri
      • Cape Girardeau, Missouri, Stati Uniti, 63703
        • Reclutamento
        • Saint Francis Medical Center
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 573-334-2230
          • Email: sfmc@sfmc.net
      • City of Saint Peters, Missouri, Stati Uniti, 63376
        • Reclutamento
        • Siteman Cancer Center at Saint Peters Hospital
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • Creve Coeur, Missouri, Stati Uniti, 63141
        • Reclutamento
        • Siteman Cancer Center at West County Hospital
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • Farmington, Missouri, Stati Uniti, 63640
        • Reclutamento
        • Parkland Health Center - Farmington
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 314-996-5569
      • Kansas City, Missouri, Stati Uniti, 64154
        • Reclutamento
        • University of Kansas Cancer Center - North
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Kansas City, Missouri, Stati Uniti, 64108
        • Reclutamento
        • University Health Truman Medical Center
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 816-404-4375
      • Kansas City, Missouri, Stati Uniti, 64116
        • Reclutamento
        • University of Kansas Cancer Center - Briarcliff
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 913-588-3671
      • Lee's Summit, Missouri, Stati Uniti, 64064
        • Reclutamento
        • University of Kansas Cancer Center - Lee's Summit
        • Investigatore principale:
          • Marc S. Hoffmann
        • Contatto:
      • Sainte Genevieve, Missouri, Stati Uniti, 63670
        • Reclutamento
        • Sainte Genevieve County Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 314-996-5569
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Washington University School of Medicine
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • St Louis, Missouri, Stati Uniti, 63129
        • Reclutamento
        • Siteman Cancer Center-South County
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • St Louis, Missouri, Stati Uniti, 63136
        • Reclutamento
        • Siteman Cancer Center at Christian Hospital
        • Contatto:
        • Investigatore principale:
          • Dilan A. Patel
      • St Louis, Missouri, Stati Uniti, 63131
        • Reclutamento
        • Missouri Baptist Medical Center
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 314-996-5569
      • Sullivan, Missouri, Stati Uniti, 63080
        • Reclutamento
        • Missouri Baptist Sullivan Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 314-996-5569
    • Montana
      • Anaconda, Montana, Stati Uniti, 59711
        • Reclutamento
        • Community Hospital of Anaconda
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59101
        • Reclutamento
        • Billings Clinic Cancer Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Bozeman, Montana, Stati Uniti, 59715
        • Reclutamento
        • Bozeman Health Deaconess Hospital
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Great Falls, Montana, Stati Uniti, 59405
        • Reclutamento
        • Benefis Sletten Cancer Institute
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Kalispell, Montana, Stati Uniti, 59901
        • Reclutamento
        • Logan Health Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Missoula, Montana, Stati Uniti, 59804
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • New Jersey
      • Cherry Hill, New Jersey, Stati Uniti, 08002
        • Reclutamento
        • Jefferson Cherry Hill Hospital
        • Contatto:
        • Investigatore principale:
          • Michael Wysota
      • Jersey City, New Jersey, Stati Uniti, 07302
        • Reclutamento
        • Jersey City Medical Center
        • Investigatore principale:
          • Joanna M. Rhodes
        • Contatto:
      • Livingston, New Jersey, Stati Uniti, 07039
        • Reclutamento
        • Cooperman Barnabas Medical Center
        • Investigatore principale:
          • Joanna M. Rhodes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 973-322-5200
      • Long Branch, New Jersey, Stati Uniti, 07740
        • Reclutamento
        • Monmouth Medical Center
        • Investigatore principale:
          • Joanna M. Rhodes
        • Contatto:
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Reclutamento
        • Rutgers Cancer Institute of New Jersey
        • Investigatore principale:
          • Joanna M. Rhodes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 732-235-7356
      • Sewell, New Jersey, Stati Uniti, 08080
        • Reclutamento
        • Sidney Kimmel Cancer Center Washington Township
        • Contatto:
        • Investigatore principale:
          • Michael Wysota
    • New York
      • Glens Falls, New York, Stati Uniti, 12801
        • Sospeso
        • Glens Falls Hospital
      • New York, New York, Stati Uniti, 10029
        • Reclutamento
        • Mount Sinai Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-824-7309
          • Email: CCTO@mssm.edu
        • Investigatore principale:
          • Suchitra Sundaram
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 585-275-5830
        • Investigatore principale:
          • Paul M. Barr
      • Webster, New York, Stati Uniti, 14580
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Reclutamento
        • UNC Lineberger Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Christopher E. Jensen
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
        • Investigatore principale:
          • Danielle M. Brander
      • Hendersonville, North Carolina, Stati Uniti, 28791
        • Reclutamento
        • Margaret R Pardee Memorial Hospital
        • Contatto:
        • Investigatore principale:
          • John K. Hill
    • North Dakota
      • Bismarck, North Dakota, Stati Uniti, 58501
      • Fargo, North Dakota, Stati Uniti, 58122
      • Fargo, North Dakota, Stati Uniti, 58103
        • Reclutamento
        • Essentia Health Cancer Center-South University Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Fargo, North Dakota, Stati Uniti, 58122
    • Ohio
      • Akron, Ohio, Stati Uniti, 44307
        • Reclutamento
        • Cleveland Clinic Akron General
        • Contatto:
        • Investigatore principale:
          • Taylor Brooks
      • Athens, Ohio, Stati Uniti, 45701
        • Reclutamento
        • OhioHealth O'Bleness Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Avon, Ohio, Stati Uniti, 44011
        • Reclutamento
        • Avon - Richard E Jacobs Health Center
        • Contatto:
        • Investigatore principale:
          • Taylor Brooks
      • Cleveland, Ohio, Stati Uniti, 44195
        • Reclutamento
        • Cleveland Clinic Foundation
        • Contatto:
        • Investigatore principale:
          • Taylor Brooks
      • Cleveland, Ohio, Stati Uniti, 44111
        • Reclutamento
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • Contatto:
        • Investigatore principale:
          • Taylor Brooks
      • Columbus, Ohio, Stati Uniti, 43214
        • Reclutamento
        • Columbus Oncology and Hematology Associates Inc
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Columbus, Ohio, Stati Uniti, 43214
        • Reclutamento
        • Riverside Methodist Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Columbus, Ohio, Stati Uniti, 43215
        • Reclutamento
        • Grant Medical Center
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Columbus, Ohio, Stati Uniti, 43228
        • Reclutamento
        • Doctors Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • Ohio State University Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Jennifer A. Woyach
      • Delaware, Ohio, Stati Uniti, 43015
        • Reclutamento
        • Delaware Health Center-Grady Cancer Center
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Delaware, Ohio, Stati Uniti, 43015
        • Reclutamento
        • Grady Memorial Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Dublin, Ohio, Stati Uniti, 43016
        • Reclutamento
        • Columbus Oncology and Hematology Associates
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Dublin, Ohio, Stati Uniti, 43016
        • Reclutamento
        • Dublin Methodist Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Mansfield, Ohio, Stati Uniti, 44903
        • Reclutamento
        • OhioHealth Mansfield Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Marion, Ohio, Stati Uniti, 43302
        • Reclutamento
        • OhioHealth Marion General Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Mayfield Heights, Ohio, Stati Uniti, 44124
        • Reclutamento
        • Hillcrest Hospital Cancer Center
        • Contatto:
        • Investigatore principale:
          • Taylor Brooks
      • Pickerington, Ohio, Stati Uniti, 43147
        • Reclutamento
        • OhioHealth Pickerington Methodist Hospital
        • Contatto:
        • Investigatore principale:
          • Basem M. William
      • Westerville, Ohio, Stati Uniti, 43082
        • Reclutamento
        • OhioHealth Westerville Medical Campus/Westerville Cancer Center
        • Contatto:
        • Investigatore principale:
          • Basem M. William
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Swaroopa PonnamReddy
    • Oregon
      • Baker City, Oregon, Stati Uniti, 97814
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Baker City
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Newberg, Oregon, Stati Uniti, 97132
        • Reclutamento
        • Providence Newberg Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Ontario, Oregon, Stati Uniti, 97914
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contatto:
        • Investigatore principale:
          • Christopher M. Reynolds
      • Oregon City, Oregon, Stati Uniti, 97045
        • Reclutamento
        • Providence Willamette Falls Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97213
        • Reclutamento
        • Providence Portland Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97225
        • Reclutamento
        • Providence Saint Vincent Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97227
        • Reclutamento
        • Kaiser Permanente Northwest
        • Contatto:
        • Investigatore principale:
          • Abdul Hai Mansoor
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Reclutamento
        • Geisinger Medical Center
        • Investigatore principale:
          • Joseph J. Vadakara
        • Contatto:
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Thomas Jefferson University Hospital
        • Contatto:
        • Investigatore principale:
          • Michael Wysota
      • Philadelphia, Pennsylvania, Stati Uniti, 19114
        • Reclutamento
        • Jefferson Torresdale Hospital
        • Contatto:
        • Investigatore principale:
          • Michael Wysota
      • Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
        • Reclutamento
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contatto:
        • Investigatore principale:
          • Joseph J. Vadakara
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Reclutamento
        • Rhode Island Hospital
        • Investigatore principale:
          • Thomas Ollila
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 401-444-1488
    • South Dakota
      • Aberdeen, South Dakota, Stati Uniti, 57401
        • Reclutamento
        • Avera Cancer Institute-Aberdeen
        • Contatto:
        • Investigatore principale:
          • Shristi Upadhyay Banskota
      • Mitchell, South Dakota, Stati Uniti, 57301
        • Reclutamento
        • Avera Cancer Institute - Mitchell
        • Contatto:
        • Investigatore principale:
          • Shristi Upadhyay Banskota
      • Pierre, South Dakota, Stati Uniti, 57501
        • Reclutamento
        • Avera Cancer Institute at Pierre
        • Contatto:
        • Investigatore principale:
          • Shristi Upadhyay Banskota
      • Sioux Falls, South Dakota, Stati Uniti, 57104
        • Reclutamento
        • Sanford Cancer Center Oncology Clinic
        • Investigatore principale:
          • Daniel Almquist
        • Contatto:
      • Sioux Falls, South Dakota, Stati Uniti, 57117-5134
        • Reclutamento
        • Sanford USD Medical Center - Sioux Falls
        • Investigatore principale:
          • Daniel Almquist
        • Contatto:
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Reclutamento
        • Avera Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Shristi Upadhyay Banskota
      • Yankton, South Dakota, Stati Uniti, 57078
        • Reclutamento
        • Avera Cancer Institute at Yankton
        • Contatto:
        • Investigatore principale:
          • Shristi Upadhyay Banskota
    • Tennessee
      • Collierville, Tennessee, Stati Uniti, 38017
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • Memphis, Tennessee, Stati Uniti, 38120
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
    • Texas
      • Abilene, Texas, Stati Uniti, 79601
        • Reclutamento
        • Hendrick Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 325-670-6340
        • Investigatore principale:
          • Jose C. Velasco Di Domenico
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigatore principale:
          • Bharadhwaj Kolipakkam
        • Contatto:
      • Tappahannock, Virginia, Stati Uniti, 22560
        • Reclutamento
        • VCU Health Tappahannock Hospital
        • Investigatore principale:
          • Bharadhwaj Kolipakkam
        • Contatto:
    • Washington
      • Edmonds, Washington, Stati Uniti, 98026
        • Reclutamento
        • Swedish Cancer Institute-Edmonds
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Issaquah, Washington, Stati Uniti, 98029
        • Sospeso
        • Swedish Cancer Institute-Issaquah
      • Seattle, Washington, Stati Uniti, 98122
        • Reclutamento
        • Swedish Medical Center-First Hill
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
    • Wisconsin
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Reclutamento
        • Duluth Clinic Ashland
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • Reclutamento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigatore principale:
          • Anthony J. Jaslowski
        • Contatto:
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigatore principale:
          • Anthony J. Jaslowski
        • Contatto:
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Reclutamento
        • Gundersen Lutheran Medical Center
        • Contatto:
        • Investigatore principale:
          • Michael O. Ojelabi
      • Madison, Wisconsin, Stati Uniti, 53705
        • Reclutamento
        • William S Middleton VA Medical Center
        • Investigatore principale:
          • Christopher D. Fletcher
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 17007 608-256-1901
      • Mukwonago, Wisconsin, Stati Uniti, 53149
        • Reclutamento
        • ProHealth D N Greenwald Center
        • Contatto:
        • Investigatore principale:
          • Timothy R. Wassenaar
      • Oconomowoc, Wisconsin, Stati Uniti, 53066
        • Reclutamento
        • ProHealth Oconomowoc Memorial Hospital
        • Investigatore principale:
          • Timothy R. Wassenaar
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 262-928-7878
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigatore principale:
          • Anthony J. Jaslowski
        • Contatto:
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235-1495
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigatore principale:
          • Anthony J. Jaslowski
        • Contatto:
      • Waukesha, Wisconsin, Stati Uniti, 53188
        • Reclutamento
        • UW Cancer Center at ProHealth Care
        • Investigatore principale:
          • Timothy R. Wassenaar
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility

  • STEP 0: Patients must be diagnosed with CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:

    • ≥ 5 x10^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)
    • On morphologic review, the leukemic cells must be small mature lymphocytes
    • Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics

  • STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:

    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) < 10 g/dL, platelet count < 100,000/mm^3

    • Massive (> 6 cm below the costal margin), progressive or symptomatic splenomegaly

    • Massive nodes (ie, > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy

    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy

    • Constitutional symptoms, which include any of the following:

      • Unintentional weight loss of ≥ 10% within the previous 6 months
      • Significant fatigue (ie. Eastern Cooperative Oncology Group [ECOG] performance status [PS] ≥ 2)
      • Fevers >100.5 °F or 38.0°C for 2 weeks or more without evidence of infection
      • Night sweats > 1 month without evidence of infection

  • STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)

  • STEP 0: Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration

  • STEP 0: Age ≥ 65 years

  • STEP 0: ECOG performance status ≤ 2

  • STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment

  • STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better.

Patients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment

  • STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage
  • STEP 0: No patients with known active progressive central nervous system (CNS) disease
  • STEP 0: No known medical condition causing an inability to swallow oral formulations of agents
  • STEP 1: The adaptive report confirming a measurable and trackable B cell clone
  • STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician
  • STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document
  • STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
  • STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
  • STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4/5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug
  • STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mm3 unless due to marrow involvement
  • STEP 1: Platelet count ≥ 30,000/mm3
  • STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)
  • STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver
  • STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL/min
  • STEP 1: Urine protein to creatinine ratio < 1 or urine protein ≤ 1+
  • STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ
  • STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm 1 (zanubrutinib)

Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with at least partial remission continue therapy as described above. Patients with progressive disease proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection throughout the study.
Procedura: Biospecimen Collection

Undergo blood sample collection

Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedura: Computed Tomography

Undergo CT scan

Altri nomi:
  • TAC
Altro: Survey Administration

Ancillary studies

Droga: Zanubrutinib

Given PO
Sperimentale: Arm 2 (zanubrutinib and sonrotoclax)

Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Starting cycle 4 day 1 patients also receive sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with undetectable MRD and a response of PR, PR-L, CR, CCR or CRi stop therapy at cycle 15 day 28 and proceed to follow up. Patients with detectable MRD and an objective response to therapy are re-randomized to arm 2B or arm 2C.

ARM 2B: Patients continue zanubrutinib PO BID sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for an additonal 12 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2C: Patients discontinue therapy starting at cycle 15 day 28 and proceed to follow up.

Patients undergo CT scan, bone marrow aspiration and blood sample collection
Procedura: Biospecimen Collection

Undergo blood sample collection

Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedura: Computed Tomography

Undergo CT scan

Altri nomi:
  • TAC
Altro: Survey Administration

Ancillary studies

Droga: Zanubrutinib

Given PO

Droga: Sonrotoclax

Given PO

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression free survival (PFS)
Lasso di tempo: From initial randomization date until the earlier of disease progression or death from any cause, up to 10 years

From initial randomization date until the earlier of disease progression or death from any cause. PFS estimates for zanubrutinib plus sonrotoclax therapy to continuous Zanubrutinib.
From initial randomization date until the earlier of disease progression or death from any cause, up to 10 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS for patients with MRD detectable disease treated with fixed duration zanubrutinib sonrotoclax versus patients with MRD detectable disease who receive one additional year of combination therapy
Lasso di tempo: up to 10 years

Undetectable (u) MRD will be defined as < 10 in 1,000,000 (less than 1 in 10^-5 [uMRD5]) on peripheral blood, and the depth of response below that level, (i.e. down to 10^-6 [uMRD6]), will also be collected. Kaplan-Meier will be used to estimate survival curves, log-rank tests to compare between survival curves, and hazard ration (HRs) and associated 95% CIs will be reported.
up to 10 years
Overall survival
Lasso di tempo: Up to 10 years

OS will be summarized using Kaplan-Meier methodology, with hazard ratios from a stratified Cox proportional hazards model and log-rank test results provided.
Up to 10 years
Percentage of patients with MRD detectable disease who convert to uMRD after receiving an extra year of combination therapy on the MRD-guided Zanubrutinib sonrotoclax therapy arm
Lasso di tempo: Up to 10 years

Proportions of number of MRD+ to uMRD conversion by total number of evaluable patients will be estimated with their corresponding 95% CIs.
Up to 10 years
Overall response rate among treatment arms
Lasso di tempo: Up to 10 years

Overall response rate is defined as the highest response achieved during the first 15 cycles of treatment. A response is defined as a patients achieving PR+.
Up to 10 years
Time to next CLL/SLL therapy
Lasso di tempo: Up to 10 years

Kaplan-Meier estimates and 95% CIs of TTNT. Time is measured as the time from the end of initial treatment to the initiation of subsequent treatment.
Up to 10 years
Adverse Event Rates and Severity
Lasso di tempo: Up to 10 years

Frequency and severity of adverse events and tolerability for each embedded treatment regimen will be collected and summarized using descriptive statistics.
Up to 10 years
Patient-reported symptomatic adverse events
Lasso di tempo: Up to 10 years

As assessed by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than 0 will be compared between arms using Fisher's exact test. Similarly, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than or equal to 3 will be compared between arms using Fisher's exact test.
Up to 10 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Jennifer R Brown, MD, Alliance for Clinical Trials in Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 aprile 2026

Completamento primario (Stimato)

30 settembre 2028

Completamento dello studio (Stimato)

30 settembre 2038

Date di iscrizione allo studio

Primo inviato

5 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2026

Primo Inserito (Effettivo)

7 gennaio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A042302
  • NCI-2025-08923 (Altro identificatore: NCI Clinical Trial Reporting Program)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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