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Testing av effektiviteten til en kombinasjonsmålrettet terapi (ViPOR) for pasienter med residiverende og/eller refraktært aggressivt B-celle lymfom

20. oktober 2026 oppdatert av: National Cancer Institute (NCI)

En fase 2-studie av Venetoclax, Ibrutinib, Prednison, Obinutuzumab og Revlimid (ViPOR) i residiverende eller refraktær CD10-negativt diffust stort B-celle lymfom (DLBCL) og høygradig B-celle lymfom med MYC og BCL2 refraktært -DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax 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. Ibrutinib 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 at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. To evaluate the complete response (CR) rate of ViPOR in relapsed/refractory (R/R):

Ia. CD10-negative DLBCL; and Ib. CD10-positive or negative high-grade B-cell lymphoma (HGBCL) with MYC and BCL2 (with or without BCL6) translocations (HGBCL-double hit [DH]-BCL2).

SECONDARY OBJECTIVES:

I. To evaluate the complete response (CR) rate of ViPOR in relapsed/refractory (R/R):

Ia. CD10-negative activated B-cell (ABC) DLBCL; and Ib. CD10-negative non-ABC (i.e., unclassified or germinal center B-cell [GCB]) DLBCL.

II. To evaluate the overall response rate (ORR), duration of response (DOR), event-free survival (EFS), time to progression (TTP), progression-free survival (PFS), overall survival (OS), and the safety & toxicity profile of ViPOR in relapsed/refractory (R/R):

IIa. CD10-negative ABC DLBCL; and IIb. CD10-negative non-ABC (i.e., unclassified or GCB) DLBCL; and IIc. CD10-positive or negative HGBCL-DH-BCL2.

EXPLORATORY OBJECTIVES:

I. To assess response and outcome to ViPOR based on molecular DLBCL subtype by cell-of-origin (COO) testing using Lymph2Cx gene-expression profiling (GEP).

II. To assess response and outcome to ViPOR based on genetic DLBCL subtype by LymphGen classification using whole exome sequencing (WES), whole genome sequencing (WGS), and ribonucleic acid (RNA)-sequencing (RNA-seq).

III. To determine other molecular correlates of response or resistance to ViPOR therapy.

IV. To determine early molecular correlates of response or resistance as well as the rate of complete molecular remission, as determined by assays for circulating-tumor deoxyribonucleic acid (DNA) (ctDNA).

OUTLINE:

Patients receive venetoclax orally (PO) once daily (QD) on days 2-14, ibrutinib PO QD on days 1-14, prednisone PO QD on days 1-7, obinutuzumab intravenously (IV) on days 1 and 2, and lenalidomide (Revlimid) PO QD on days 1-14 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, positron emission tomography (PET), computed tomography (CT) and/or magnetic resonance imaging (MRI) and optional tumor biopsy and bone marrow aspiration and biopsy throughout the study.

After completion of study treatment, patients are followed up every 6 months for 2 years, yearly during years 3-5, and then for survival for up to 10 years from the date of registration.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85719
        • Aktiv, ikke rekrutterende
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Forente stater, 85719
        • Aktiv, ikke rekrutterende
        • University of Arizona Cancer Center-North Campus
    • California
      • Los Angeles, California, Forente stater, 90048
        • Rekruttering
        • Cedars-Sinai Medical Center
        • Hovedetterforsker:
          • Justin M. Darrah
        • Ta kontakt med:
    • Connecticut
      • Derby, Connecticut, Forente stater, 06418
        • Rekruttering
        • Smilow Cancer Hospital-Derby Care Center
        • Hovedetterforsker:
          • Shalin Kothari
        • Ta kontakt med:
      • Guilford, Connecticut, Forente stater, 06437
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Guilford
        • Hovedetterforsker:
          • Shalin Kothari
        • Ta kontakt med:
      • New Haven, Connecticut, Forente stater, 06520
        • Rekruttering
        • Yale University
        • Hovedetterforsker:
          • Shalin Kothari
        • Ta kontakt med:
    • Idaho
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Rekruttering
        • Kootenai Health - Coeur d'Alene
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Post Falls, Idaho, Forente stater, 83854
        • Rekruttering
        • Kootenai Clinic Cancer Services - Post Falls
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Sandpoint, Idaho, Forente stater, 83864
        • Rekruttering
        • Kootenai Clinic Cancer Services - Sandpoint
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Rekruttering
        • Northwestern University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Reem Karmali
      • Danville, Illinois, Forente stater, 61832
        • Suspendert
        • Carle at The Riverfront
      • DeKalb, Illinois, Forente stater, 60115
        • Rekruttering
        • Northwestern Medicine Cancer Center Kishwaukee
        • Ta kontakt med:
        • Hovedetterforsker:
          • Reem Karmali
      • Effingham, Illinois, Forente stater, 62401
        • Suspendert
        • Carle Physician Group-Effingham
      • Geneva, Illinois, Forente stater, 60134
        • Rekruttering
        • Northwestern Medicine Cancer Center Delnor
        • Ta kontakt med:
        • Hovedetterforsker:
          • Reem Karmali
      • Glenview, Illinois, Forente stater, 60026
        • Rekruttering
        • Northwestern Medicine Glenview Outpatient Center
        • Hovedetterforsker:
          • Reem Karmali
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 312-695-1102
      • Grayslake, Illinois, Forente stater, 60030
        • Rekruttering
        • Northwestern Medicine Grayslake Outpatient Center
        • Hovedetterforsker:
          • Reem Karmali
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 312-695-1102
      • Lake Forest, Illinois, Forente stater, 60045
        • Rekruttering
        • Northwestern Medicine Lake Forest Hospital
        • Hovedetterforsker:
          • Reem Karmali
        • Ta kontakt med:
      • Mattoon, Illinois, Forente stater, 61938
        • Suspendert
        • Carle Physician Group-Mattoon/Charleston
      • Normal, Illinois, Forente stater, 61761
        • Suspendert
        • Carle Cancer Institute Normal
      • Normal, Illinois, Forente stater, 61761
        • Suspendert
        • Carle BroMenn Medical Center
      • Oak Brook, Illinois, Forente stater, 60523
      • Orland Park, Illinois, Forente stater, 60462
      • Shiloh, Illinois, Forente stater, 62269
        • Rekruttering
        • Memorial Hospital East
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
      • Urbana, Illinois, Forente stater, 61801
        • Suspendert
        • Carle Cancer Center
      • Warrenville, Illinois, Forente stater, 60555
        • Rekruttering
        • Northwestern Medicine Cancer Center Warrenville
        • Ta kontakt med:
        • Hovedetterforsker:
          • Reem Karmali
    • Indiana
      • Crown Point, Indiana, Forente stater, 46307
        • Rekruttering
        • Northwest Cancer Center - Crown Point
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
      • Dyer, Indiana, Forente stater, 46311
        • Rekruttering
        • Northwest Oncology LLC
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 219-924-8178
      • Hobart, Indiana, Forente stater, 46342
        • Rekruttering
        • Saint Mary Medical Center
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
      • Indianapolis, Indiana, Forente stater, 46312
        • Rekruttering
        • Saint Catherine Hospital
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
      • Munster, Indiana, Forente stater, 46321
        • Rekruttering
        • The Community Hospital
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 219-836-3349
      • Munster, Indiana, Forente stater, 46321
        • Rekruttering
        • Women's Diagnostic Center - Munster
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
      • Valparaiso, Indiana, Forente stater, 46383
        • Rekruttering
        • Northwest Cancer Center - Valparaiso
        • Hovedetterforsker:
          • Suparna Mantha
        • Ta kontakt med:
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Rekruttering
        • Mary Greeley Medical Center
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Ames, Iowa, Forente stater, 50010
        • Rekruttering
        • McFarland Clinic - Ames
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
      • Ankeny, Iowa, Forente stater, 50023
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Boone, Iowa, Forente stater, 50036
        • Suspendert
        • McFarland Clinic - Boone
      • Carroll, Iowa, Forente stater, 51401
        • Rekruttering
        • Saint Anthony Regional Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Rekruttering
        • Mercy Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 319-365-4673
        • Hovedetterforsker:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Rekruttering
        • Oncology Associates at Mercy Medical Center
        • Hovedetterforsker:
          • Deborah W. Wilbur
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 319-363-2690
      • Clive, Iowa, Forente stater, 50325
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50314
        • Rekruttering
        • Broadlawns Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-282-2200
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50309
        • Rekruttering
        • Iowa Methodist Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-6727
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50309
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50314
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Forente stater, 50501
        • Rekruttering
        • McFarland Clinic - Trinity Cancer Center
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Fort Dodge, Iowa, Forente stater, 50501
        • Rekruttering
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Hovedetterforsker:
          • Seema Harichand-Herdt
        • Ta kontakt med:
      • Jefferson, Iowa, Forente stater, 50129
        • Suspendert
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forente stater, 50158
        • Rekruttering
        • McFarland Clinic - Marshalltown
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Waukee, Iowa, Forente stater, 50263
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Suspendert
        • Ochsner Medical Center Jefferson
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • Rekruttering
        • National Institutes of Health Clinical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-411-1222
        • Hovedetterforsker:
          • Christopher J. Melani
      • Bethesda, Maryland, Forente stater, 20889-5600
        • Rekruttering
        • Walter Reed National Military Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 301-319-2100
        • Hovedetterforsker:
          • Christin Destefano
    • Michigan
      • Escanaba, Michigan, Forente stater, 49829
        • Rekruttering
        • OSF Saint Francis Hospital and Medical Group
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Manistique, Michigan, Forente stater, 49854
        • Rekruttering
        • Schoolcraft Memorial Hospital
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
    • Minnesota
      • Brainerd, Minnesota, Forente stater, 56401
        • Rekruttering
        • Essentia Health Saint Joseph's Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Deer River, Minnesota, Forente stater, 56636
        • Rekruttering
        • Essentia Health - Deer River Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Duluth, Minnesota, Forente stater, 55805
        • Rekruttering
        • Essentia Health Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Hibbing, Minnesota, Forente stater, 55746
        • Rekruttering
        • Essentia Health Hibbing Clinic
        • Hovedetterforsker:
          • Bret E. Friday
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 218-786-3308
      • Sandstone, Minnesota, Forente stater, 55072
        • Rekruttering
        • Essentia Health Sandstone
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Virginia, Minnesota, Forente stater, 55792
        • Rekruttering
        • Essentia Health Virginia Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
    • Missouri
      • City of Saint Peters, Missouri, Forente stater, 63376
        • Rekruttering
        • Siteman Cancer Center at Saint Peters Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
      • Creve Coeur, Missouri, Forente stater, 63141
        • Rekruttering
        • Siteman Cancer Center at West County Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
      • St Louis, Missouri, Forente stater, 63129
        • Rekruttering
        • Siteman Cancer Center-South County
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
      • St Louis, Missouri, Forente stater, 63136
        • Rekruttering
        • Siteman Cancer Center at Christian Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brad S. Kahl
    • Montana
      • Anaconda, Montana, Forente stater, 59711
        • Suspendert
        • Community Hospital of Anaconda
      • Billings, Montana, Forente stater, 59101
        • Rekruttering
        • Billings Clinic Cancer Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Bozeman, Montana, Forente stater, 59715
        • Suspendert
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Forente stater, 59405
        • Rekruttering
        • Benefis Sletten Cancer Institute
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Kalispell, Montana, Forente stater, 59901
        • Suspendert
        • Logan Health Medical Center
      • Missoula, Montana, Forente stater, 59804
        • Rekruttering
        • Community Medical Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
    • Nebraska
      • Bellevue, Nebraska, Forente stater, 68123
        • Rekruttering
        • Nebraska Medicine-Bellevue
        • Ta kontakt med:
        • Hovedetterforsker:
          • Snegha Ananth
      • Omaha, Nebraska, Forente stater, 68198
        • Rekruttering
        • University of Nebraska Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Snegha Ananth
      • Omaha, Nebraska, Forente stater, 68118
        • Rekruttering
        • Nebraska Medicine-Village Pointe
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 402-559-5600
        • Hovedetterforsker:
          • Snegha Ananth
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Rekruttering
        • Roswell Park Cancer Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alex Niu
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Suspendert
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58103
        • Rekruttering
        • Essentia Health Cancer Center-South University Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
    • Ohio
      • Canton, Ohio, Forente stater, 44710
        • Rekruttering
        • Aultman Health Foundation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Aarthi Rajkumar
      • Cincinnati, Ohio, Forente stater, 45219
        • Rekruttering
        • University of Cincinnati Cancer Center-UC Medical Center
        • Hovedetterforsker:
          • Tahir Latif
        • Ta kontakt med:
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathryn Lurain
      • West Chester, Ohio, Forente stater, 45069
        • Rekruttering
        • University of Cincinnati Cancer Center-West Chester
        • Hovedetterforsker:
          • Tahir Latif
        • Ta kontakt med:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Suspendert
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Hood River, Oregon, Forente stater, 97031
        • Rekruttering
        • Providence Hood River Memorial Hospital
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
      • Newberg, Oregon, Forente stater, 97132
        • Rekruttering
        • Providence Newberg Medical Center
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
      • Oregon City, Oregon, Forente stater, 97045
        • Rekruttering
        • Providence Willamette Falls Medical Center
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
      • Portland, Oregon, Forente stater, 97213
        • Rekruttering
        • Providence Portland Medical Center
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
      • Portland, Oregon, Forente stater, 97225
        • Rekruttering
        • Providence Saint Vincent Medical Center
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Rekruttering
        • Thomas Jefferson University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Wysota
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Rekruttering
        • University of Vermont Medical Center
        • Hovedetterforsker:
          • James N. Gerson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 802-656-4101
          • E-post: rpo@uvm.edu
      • Burlington, Vermont, Forente stater, 05405
        • Rekruttering
        • University of Vermont and State Agricultural College
        • Hovedetterforsker:
          • James N. Gerson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 802-656-8990
          • E-post: rpo@uvm.edu
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • Rekruttering
        • University of Virginia Cancer Center
        • Hovedetterforsker:
          • Craig A. Portell
        • Ta kontakt med:
      • Richmond, Virginia, Forente stater, 23298
        • Rekruttering
        • VCU Massey Comprehensive Cancer Center
        • Hovedetterforsker:
          • Bruce O. Hough
        • Ta kontakt med:
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Rekruttering
        • Swedish Medical Center-First Hill
        • Hovedetterforsker:
          • Alison K. Conlin
        • Ta kontakt med:
    • Wisconsin
      • Ashland, Wisconsin, Forente stater, 54806
        • Rekruttering
        • Duluth Clinic Ashland
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Green Bay, Wisconsin, Forente stater, 54301
        • Rekruttering
        • Saint Vincent Hospital Cancer Center Green Bay
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Green Bay, Wisconsin, Forente stater, 54303
        • Rekruttering
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Janesville, Wisconsin, Forente stater, 53548
        • Rekruttering
        • Mercyhealth Hospital and Cancer Center - Janesville
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emily G. Robinson
      • La Crosse, Wisconsin, Forente stater, 54601
        • Rekruttering
        • Gundersen Lutheran Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kurt Oettel
      • Madison, Wisconsin, Forente stater, 53792
        • Rekruttering
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Hovedetterforsker:
          • Priyanka Pophali
        • Ta kontakt med:
      • Madison, Wisconsin, Forente stater, 53718
        • Rekruttering
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Hovedetterforsker:
          • Priyanka Pophali
        • Ta kontakt med:
      • Menomonee Falls, Wisconsin, Forente stater, 53051
        • Rekruttering
        • Froedtert Menomonee Falls Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 262-257-5100
        • Hovedetterforsker:
          • Kaitlin Annunzio
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Rekruttering
        • Medical College of Wisconsin
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 414-805-3666
        • Hovedetterforsker:
          • Kaitlin Annunzio
      • Mukwonago, Wisconsin, Forente stater, 53149
        • Rekruttering
        • ProHealth D N Greenwald Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Timothy R. Wassenaar
      • New Berlin, Wisconsin, Forente stater, 53151
        • Rekruttering
        • Froedtert and MCW Moorland Reserve Health Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
        • Hovedetterforsker:
          • Kaitlin Annunzio
      • Oak Creek, Wisconsin, Forente stater, 53154
        • Rekruttering
        • Drexel Town Square Health Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
        • Hovedetterforsker:
          • Kaitlin Annunzio
      • Oconomowoc, Wisconsin, Forente stater, 53066
        • Rekruttering
        • ProHealth Oconomowoc Memorial Hospital
        • Hovedetterforsker:
          • Timothy R. Wassenaar
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 262-928-7878
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Rekruttering
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Rekruttering
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Rekruttering
        • Sheboygan Physicians Group
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Spooner, Wisconsin, Forente stater, 54801
        • Rekruttering
        • Essentia Health-Spooner Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bret E. Friday
      • Sturgeon Bay, Wisconsin, Forente stater, 54235-1495
        • Rekruttering
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Hovedetterforsker:
          • Brian L. Burnette
        • Ta kontakt med:
      • Superior, Wisconsin, Forente stater, 54880
        • Rekruttering
        • Essentia Health Saint Mary's Hospital - Superior
        • Hovedetterforsker:
          • Bret E. Friday
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 701-364-6272
      • Waukesha, Wisconsin, Forente stater, 53188
        • Rekruttering
        • UW Cancer Center at ProHealth Care
        • Hovedetterforsker:
          • Timothy R. Wassenaar
        • Ta kontakt med:
      • West Bend, Wisconsin, Forente stater, 53095
        • Rekruttering
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 414-805-0505
        • Hovedetterforsker:
          • Kaitlin Annunzio

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient must be ≥ 18 years of age

  • Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:

    • Cohort 1: CD10-negative DLBCL, which includes:

      • CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL)
      • CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL)
      • CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)
      • CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)
      • CD10-negative T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL) OR

    • Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)

      • NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration

  • Patient must have relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen

  • Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL)

  • Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used.

    • All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU/mL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment.
    • A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy

  • Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide

  • Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment

  • Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Absolute neutrophil count (ANC) ≥ 1,000/mcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration)

  • Hemoglobin ≥ 8 g/dL (obtained ≤ 7 days prior to registration)

  • Platelets ≥ 75,000/mcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration)

  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration)

  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

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

  • 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

  • Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL)

  • Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration.

    • NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution

  • Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol

  • Patient must not have evidence of an active infection at the time of registration

  • Patient must not have the following current or prior anti-cancer treatment:

    • Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration

      • NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted

    • More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates

      • NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy/chimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy

    • Radio- or toxin-immunoconjugates within 10 weeks prior to registration

    • Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug [IMiD])

    • Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration

    • Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration

      • NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure
      • NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia)

  • 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 should be class 2B or better

  • Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis

    • NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis

  • Patient must have measurable disease

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment (ViPOR)

Patients receive venetoclax PO QD on days 2-14, ibrutinib PO QD on days 1-14, prednisone PO QD on days 1-7, obinutuzumab IV on days 1 and 2, and Revlimid PO QD on days 1-14 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, PET, CT and/or MRI and optional tumor biopsy and bone marrow aspiration and biopsy throughout the study.
Legemiddel: Prednisone

Given PO

Andre navn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Legemiddel: Lenalidomide

Given PO

Andre navn:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

Fremgangsmåte: Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

Andre navn:
  • Biopsi av benmarg
  • Biopsi, benmarg
Legemiddel: Ibrutinib

Given PO

Andre navn:
  • PCI-32765
  • Imbruvica
  • BTK-hemmer PCI-32765
  • CRA-032765
  • PCI32765
  • CRA 032765
  • CRA032765
  • PCI 32765
Fremgangsmåte: Positron Emission Tomography

Undergo PET

Andre navn:
  • Medisinsk bildebehandling, positronemisjonstomografi
  • KJÆLEDYR
  • PET-skanning
  • Positron Emission Tomography Scan
  • Positron-utslippstomografi
  • PT
  • Positronemisjonstomografi (prosedyre)
Legemiddel: Venetoclax

Given PO

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Biologisk: Obinutuzumab

Given IV

Andre navn:
  • Gazyva
  • RO5072759
  • GA101
  • Anti-CD20 monoklonalt antistoff R7159
  • GA-101
  • huMAB(CD20)
  • R7159
  • RO 5072759
  • RO-5072759
  • GA 101
  • R 7159
  • R-7159
Fremgangsmåte: Biopsy Procedure

Undergo optional tumor biopsy

Andre navn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete response (CR) rate (CD10-negative diffuse large B cell lymphoma [DLBCL] and high grade B-cell lymphoma with MYC and BCL2 with or without BCL6 rearrangements [HGBCL-DH-BCL2])
Tidsramme: Up to 5 years

Will be assessed using the Lugano Classification and will be defined as the complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.
Up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CR rate (CD10-negative activated B-cell [ABC] and non-ABC DLBCL)
Tidsramme: Up to 5 years

Estimates will be presented with 90% confidence intervals. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.
Up to 5 years
Overall response rate
Tidsramme: Up to 5 years

Estimates will be presented with 90% confidence intervals. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.
Up to 5 years
Duration of response (DOR)
Tidsramme: From the documented beginning of response to the time of relapse up to 10 years

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize DOR. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.
From the documented beginning of response to the time of relapse up to 10 years
Event-free survival (EFS)
Tidsramme: From study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death up to 10 years

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize EFS. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Multivariable analysis will be performed with Cox PH model and logistic/linear regression will be performed for binary/continuous endpoints variables.
From study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death up to 10 years
Time of progression (TTP)
Tidsramme: From study entry until lymphoma progression or death due to lymphoma up to 10 years

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize TTP. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Multivariable analysis will be performed with Cox PH model and logistic/linear regression will be performed for binary/continuous endpoints variables.
From study entry until lymphoma progression or death due to lymphoma up to 10 years
Progression-free survival (PFS)
Tidsramme: From entry onto study until lymphoma progression or death from any cause up to 10 years

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize PFS. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.
From entry onto study until lymphoma progression or death from any cause up to 10 years
Overall survival (OS)
Tidsramme: From date of study entry to date of death up to 10 years

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize OS. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.
From date of study entry to date of death up to 10 years
Incidence of adverse events for patients who are CD10-negative ABC DLBCL, and CD10-negative non-ABC (i.e., unclassified or germinal center B-cell) DLBCL, and CD10-positive or negative HGBCL-DH-BCL2
Tidsramme: Up to 30 days after last dose of study treatment

Toxicity data will be pooled for tabulation and analysis.
Up to 30 days after last dose of study treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Christopher J Melani, ECOG-ACRIN Cancer Research Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. oktober 2025

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

18. oktober 2024

Først innsendt som oppfylte QC-kriteriene

18. oktober 2024

Først lagt ut (Faktiske)

21. oktober 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2024-08642
  • U10CA180820 (U.S. NIH-stipend/kontrakt)
  • NCI-2024-08642 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • EA4231 (Annen identifikator: CTEP)
  • EA4231 (Annen identifikator: ECOG-ACRIN Cancer Research Group)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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