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Testa tillägget av ett nytt läkemedel, Venetoclax, till den vanliga behandlingen (Ibrutinib och Rituximab) för Waldenströms makroglobulinemi/lymfoplasmacytiskt lymfom

29 oktober 2026 uppdaterad av: National Cancer Institute (NCI)

En randomiserad fas II-studie av Ibrutinib och Rituximab med eller utan Venetoclax vid tidigare obehandlad Waldenströms makroglobulinemi (WM)/lymfoplasmacytiskt lymfom (LPL)

This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. 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. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called BTK, which may help keep cancer cells from growing. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib with rituximab or zanubrutinib alone.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. To compare the rate of very good partial response or better (VGPR or better) in previously untreated participants with Waldenström's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) who are treated upfront with ibrutinib + rituximab (IR) or zanubrutinib alone (Z) versus (vs.) venetoclax +/- rituximab (VR) regimen.

SECONDARY OBJECTIVES:

I. To compare overall response rates (ORR) in WM participants treated upfront with ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab.

II. To compare progression-free survival (PFS), time to next treatment, duration of response in WM participants treated upfront with ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab.

III. To compare the rate of complete response (CR) in WM participants treated upfront with ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab.

IV. To evaluate the safety of ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab in participants with WM.

V. To evaluate the time to VGPR in WM participants treated upfront with ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab.

VI. To evaluate the ORR in participants who progress on treatment with ibrutinib + rituximab or zanubrutinib alone and venetoclax + rituximab are crossed over to the other respective arm.

VII. To compare overall survival (OS) in WM participants treated upfront with ibrutinib + rituximab or zanubrutinib alone vs. venetoclax + rituximab.

VIII. To evaluate the rate of VGPR or better and the ORR in WM participants treated upfront with ibrutinib plus rituximab vs. those treated with zanubrutinib alone.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 of cycles 1-24 and rituximab intravenously (IV) on days 1, 8, 15, and 22 of cycles 2 and 5, or zanubrutinib PO QD or twice daily (BID) on days 1-28 of cycles 1-24. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm I may receive rituximab and venetoclax as in Arm II for up to an additional 24 cycles. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT and bone marrow biopsy and aspiration as well as blood sample collection throughout the trial.

ARM II: Patients receive venetoclax PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15, and 22 of cycles 2 and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm II may receive ibrutinib and rituximab as in Arm I for up to an additional 24 cycles. Patients undergo CT or PET/CT and bone marrow biopsy and aspiration as well as blood sample collection throughout the trial.

After completion of study treatment, patients removed from protocol prior to progression are followed every 3 months until progression, death or 5 years after initial registration, whichever occurs first. Patients followed after progression of disease are followed every 6 months until death or 5 years after initial registration.

Studietyp

Interventionell

Inskrivning (Beräknad)

92

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85719
        • Rekrytering
        • Banner University Medical Center - Tucson
        • Huvudutredare:
          • Muhammad Husnain
        • Kontakt:
      • Tucson, Arizona, Förenta staterna, 85719
        • Rekrytering
        • University of Arizona Cancer Center-North Campus
        • Huvudutredare:
          • Muhammad Husnain
        • Kontakt:
    • California
      • Irvine, California, Förenta staterna, 92618
        • Rekrytering
        • City of Hope at Irvine Lennar
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 877-467-3411
        • Huvudutredare:
          • Benjamin M. Heyman
    • Florida
      • Coral Gables, Florida, Förenta staterna, 33146
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • Coral Springs, Florida, Förenta staterna, 33065
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • Deerfield Beach, Florida, Förenta staterna, 33442
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • Doral, Florida, Förenta staterna, 33166
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Kontakt:
        • Huvudutredare:
          • Georgios Pongas
      • Hollywood, Florida, Förenta staterna, 33021
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • Jacksonville, Florida, Förenta staterna, 32224-9980
        • Rekrytering
        • Mayo Clinic in Florida
        • Huvudutredare:
          • Sikander Ailawadhi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 855-776-0015
      • Miami, Florida, Förenta staterna, 33136
        • Rekrytering
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • Miami, Florida, Förenta staterna, 33176
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
      • North Miami, Florida, Förenta staterna, 33181
        • Rekrytering
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Kontakt:
        • Huvudutredare:
          • Georgios Pongas
      • Plantation, Florida, Förenta staterna, 33324
        • Rekrytering
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Huvudutredare:
          • Georgios Pongas
    • Idaho
      • Boise, Idaho, Förenta staterna, 83706
        • Rekrytering
        • Saint Alphonsus Cancer Care Center-Boise
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Caldwell, Idaho, Förenta staterna, 83605
        • Rekrytering
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Meridian, Idaho, Förenta staterna, 83642
        • Rekrytering
        • Idaho Urologic Institute-Meridian
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Nampa, Idaho, Förenta staterna, 83687
        • Rekrytering
        • Saint Alphonsus Cancer Care Center-Nampa
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
    • Illinois
      • Centralia, Illinois, Förenta staterna, 62801
        • Rekrytering
        • Centralia Oncology Clinic
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Danville, Illinois, Förenta staterna, 61832
        • Rekrytering
        • Carle at The Riverfront
        • Huvudutredare:
          • Priyank P. Patel
        • Kontakt:
      • Decatur, Illinois, Förenta staterna, 62526
        • Rekrytering
        • Cancer Care Specialists of Illinois - Decatur
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Effingham, Illinois, Förenta staterna, 62401
        • Rekrytering
        • Carle Physician Group-Effingham
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
      • Effingham, Illinois, Förenta staterna, 62401
        • Rekrytering
        • Crossroads Cancer Center
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Mattoon, Illinois, Förenta staterna, 61938
        • Rekrytering
        • Carle Physician Group-Mattoon/Charleston
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
      • Maywood, Illinois, Förenta staterna, 60153
        • Rekrytering
        • Loyola University Medical Center
        • Huvudutredare:
          • Patrick A. Hagen
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 708-226-4357
      • O'Fallon, Illinois, Förenta staterna, 62269
        • Rekrytering
        • Cancer Care Center of O'Fallon
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Springfield, Illinois, Förenta staterna, 62702
        • Rekrytering
        • Southern Illinois University School of Medicine
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
      • Springfield, Illinois, Förenta staterna, 62702
        • Rekrytering
        • Springfield Clinic
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-444-7541
      • Springfield, Illinois, Förenta staterna, 62781
        • Rekrytering
        • Springfield Memorial Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Urbana, Illinois, Förenta staterna, 61801
        • Rekrytering
        • Carle Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
    • Iowa
      • Ames, Iowa, Förenta staterna, 50010
        • Rekrytering
        • Mary Greeley Medical Center
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Ames, Iowa, Förenta staterna, 50010
        • Rekrytering
        • McFarland Clinic - Ames
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
      • Boone, Iowa, Förenta staterna, 50036
        • Upphängd
        • McFarland Clinic - Boone
      • Fort Dodge, Iowa, Förenta staterna, 50501
        • Rekrytering
        • McFarland Clinic - Trinity Cancer Center
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Jefferson, Iowa, Förenta staterna, 50129
        • Upphängd
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Förenta staterna, 50158
        • Rekrytering
        • McFarland Clinic - Marshalltown
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
    • Massachusetts
      • Burlington, Massachusetts, Förenta staterna, 01805
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • Rekrytering
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Brighton, Michigan, Förenta staterna, 48114
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Brighton, Michigan, Förenta staterna, 48114
      • Brownstown, Michigan, Förenta staterna, 48183
        • Rekrytering
        • Henry Ford Cancer Institute-Downriver
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Canton, Michigan, Förenta staterna, 48188
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Canton, Michigan, Förenta staterna, 48188
      • Chelsea, Michigan, Förenta staterna, 48118
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Förenta staterna, 48118
      • Clarkston, Michigan, Förenta staterna, 48346
      • Clarkston, Michigan, Förenta staterna, 48346
        • Upphängd
        • Newland Medical Associates-Clarkston
      • Clinton Township, Michigan, Förenta staterna, 48038
        • Rekrytering
        • Henry Ford Macomb Hospital-Clinton Township
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Dearborn, Michigan, Förenta staterna, 48126
        • Rekrytering
        • Henry Ford Medical Center-Fairlane
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Detroit, Michigan, Förenta staterna, 48201
        • Rekrytering
        • Wayne State University/Karmanos Cancer Institute
        • Huvudutredare:
          • Andrew Kin
        • Kontakt:
      • Detroit, Michigan, Förenta staterna, 48202
        • Rekrytering
        • Henry Ford Hospital
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Farmington Hills, Michigan, Förenta staterna, 48334
        • Rekrytering
        • Weisberg Cancer Treatment Center
        • Huvudutredare:
          • Andrew Kin
        • Kontakt:
      • Flint, Michigan, Förenta staterna, 48503
        • Rekrytering
        • Genesys Hurley Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Flint, Michigan, Förenta staterna, 48503
        • Rekrytering
        • Hurley Medical Center
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Flint, Michigan, Förenta staterna, 48503
        • Upphängd
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Förenta staterna, 48503
        • Rekrytering
        • Cancer Hematology Centers - Flint
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Jackson, Michigan, Förenta staterna, 49201
        • Rekrytering
        • Allegiance Health
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Lansing, Michigan, Förenta staterna, 48912
        • Rekrytering
        • University of Michigan Health - Sparrow Lansing
        • Huvudutredare:
          • Tareq Al baghdadi
        • Kontakt:
      • Livonia, Michigan, Förenta staterna, 48154
        • Rekrytering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Novi, Michigan, Förenta staterna, 48377
        • Rekrytering
        • Henry Ford Medical Center-Columbus
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Pontiac, Michigan, Förenta staterna, 48341
        • Rekrytering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Pontiac, Michigan, Förenta staterna, 48341
        • Rekrytering
        • Michigan Healthcare Professionals Pontiac
        • Huvudutredare:
          • Tareq Al baghdadi
        • Kontakt:
      • Pontiac, Michigan, Förenta staterna, 48341
        • Rekrytering
        • Trinity Health IHA Medical Group-Alice Gustafson Center
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Saginaw, Michigan, Förenta staterna, 48604
        • Upphängd
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Förenta staterna, 48601
      • Tawas City, Michigan, Förenta staterna, 48764
      • West Bloomfield, Michigan, Förenta staterna, 48322
        • Rekrytering
        • Henry Ford West Bloomfield Hospital
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Wyandotte, Michigan, Förenta staterna, 48192
        • Rekrytering
        • Henry Ford Wyandotte Hospital
        • Huvudutredare:
          • Vijayalakshmi Donthireddy
        • Kontakt:
      • Ypsilanti, Michigan, Förenta staterna, 48106
      • Ypsilanti, Michigan, Förenta staterna, 48197
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
    • Minnesota
      • Coon Rapids, Minnesota, Förenta staterna, 55433
        • Rekrytering
        • Mercy Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Edina, Minnesota, Förenta staterna, 55435
        • Rekrytering
        • Minnesota Oncology - Edina
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Rekrytering
        • Abbott-Northwestern Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Minneapolis, Minnesota, Förenta staterna, 55415
        • Rekrytering
        • Hennepin County Medical Center
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Rochester, Minnesota, Förenta staterna, 55905
        • Rekrytering
        • Mayo Clinic in Rochester
        • Huvudutredare:
          • Sikander Ailawadhi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 855-776-0015
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • Rekrytering
        • Park Nicollet Clinic - Saint Louis Park
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Saint Paul, Minnesota, Förenta staterna, 55101
        • Rekrytering
        • Regions Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Saint Paul, Minnesota, Förenta staterna, 55102
        • Rekrytering
        • United Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
    • Missouri
      • Cape Girardeau, Missouri, Förenta staterna, 63703
        • Rekrytering
        • Saint Francis Medical Center
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 573-334-2230
          • E-post: sfmc@sfmc.net
      • City of Saint Peters, Missouri, Förenta staterna, 63376
        • Aktiv, inte rekryterande
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Förenta staterna, 63141
        • Aktiv, inte rekryterande
        • Siteman Cancer Center at West County Hospital
      • Saint Joseph, Missouri, Förenta staterna, 64506
        • Rekrytering
        • Heartland Regional Medical Center
        • Huvudutredare:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Förenta staterna, 63110
        • Aktiv, inte rekryterande
        • Washington University School of Medicine
      • St Louis, Missouri, Förenta staterna, 63128
        • Rekrytering
        • Mercy Hospital South
        • Huvudutredare:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Förenta staterna, 63129
        • Aktiv, inte rekryterande
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Förenta staterna, 63136
        • Aktiv, inte rekryterande
        • Siteman Cancer Center at Christian Hospital
    • Montana
      • Billings, Montana, Förenta staterna, 59102
        • Rekrytering
        • Saint Vincent Frontier Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-648-6274
        • Huvudutredare:
          • Patrick W. Cobb
    • New Jersey
      • Basking Ridge, New Jersey, Förenta staterna, 07920
        • Rekrytering
        • Memorial Sloan Kettering Basking Ridge
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • Middletown, New Jersey, Förenta staterna, 07748
        • Rekrytering
        • Memorial Sloan Kettering Monmouth
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • Montvale, New Jersey, Förenta staterna, 07645
        • Rekrytering
        • Memorial Sloan Kettering Bergen
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
    • New York
      • Commack, New York, Förenta staterna, 11725
        • Rekrytering
        • Memorial Sloan Kettering Commack
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • Glens Falls, New York, Förenta staterna, 12801
        • Aktiv, inte rekryterande
        • Glens Falls Hospital
      • Harrison, New York, Förenta staterna, 10604
        • Rekrytering
        • Memorial Sloan Kettering Westchester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • New York, New York, Förenta staterna, 10065
        • Rekrytering
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • New York, New York, Förenta staterna, 10032
        • Aktiv, inte rekryterande
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, Förenta staterna, 14642
        • Rekrytering
        • University of Rochester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 585-275-5830
        • Huvudutredare:
          • Clive S. Zent
      • Uniondale, New York, Förenta staterna, 11553
        • Rekrytering
        • Memorial Sloan Kettering Nassau
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Maria L. Palomba
      • Webster, New York, Förenta staterna, 14580
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28203
        • Rekrytering
        • Carolinas Medical Center/Levine Cancer Institute
        • Huvudutredare:
          • Manisha Bhutani
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Clinton, North Carolina, Förenta staterna, 28328
        • Rekrytering
        • Southeastern Medical Oncology Center-Clinton
        • Kontakt:
        • Huvudutredare:
          • Samer S. Kasbari
      • Gastonia, North Carolina, Förenta staterna, 28054
        • Rekrytering
        • Levine Cancer Institute-Gaston
        • Huvudutredare:
          • Manisha Bhutani
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Goldsboro, North Carolina, Förenta staterna, 27534
        • Rekrytering
        • Southeastern Medical Oncology Center-Goldsboro
        • Kontakt:
        • Huvudutredare:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, Förenta staterna, 28546
        • Rekrytering
        • Southeastern Medical Oncology Center-Jacksonville
        • Huvudutredare:
          • Samer S. Kasbari
        • Kontakt:
      • Monroe, North Carolina, Förenta staterna, 28112
        • Rekrytering
        • Atrium Health Union/LCI-Union
        • Huvudutredare:
          • Manisha Bhutani
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 980-442-2000
    • Ohio
      • Belpre, Ohio, Förenta staterna, 45714
        • Upphängd
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, Förenta staterna, 45601
        • Upphängd
        • Adena Regional Medical Center
      • Columbus, Ohio, Förenta staterna, 43213
        • Upphängd
        • Mount Carmel East Hospital
      • Columbus, Ohio, Förenta staterna, 43214
        • Upphängd
        • Riverside Methodist Hospital
      • Columbus, Ohio, Förenta staterna, 43222
        • Upphängd
        • Mount Carmel Health Center West
      • Columbus, Ohio, Förenta staterna, 43215
        • Upphängd
        • Grant Medical Center
      • Columbus, Ohio, Förenta staterna, 43219
        • Upphängd
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Förenta staterna, 43228
        • Upphängd
        • Doctors Hospital
      • Columbus, Ohio, Förenta staterna, 43214
        • Upphängd
        • Columbus Oncology and Hematology Associates Inc
      • Delaware, Ohio, Förenta staterna, 43015
        • Upphängd
        • Grady Memorial Hospital
      • Delaware, Ohio, Förenta staterna, 43015
        • Upphängd
        • Delaware Health Center-Grady Cancer Center
      • Dublin, Ohio, Förenta staterna, 43016
        • Upphängd
        • Dublin Methodist Hospital
      • Gahanna, Ohio, Förenta staterna, 43230
        • Upphängd
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, Förenta staterna, 43123
        • Upphängd
        • Mount Carmel Grove City Hospital
      • Lancaster, Ohio, Förenta staterna, 43130
        • Upphängd
        • Fairfield Medical Center
      • Lima, Ohio, Förenta staterna, 45801
        • Upphängd
        • Saint Rita's Medical Center
      • Mansfield, Ohio, Förenta staterna, 44903
        • Upphängd
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, Förenta staterna, 45750
        • Upphängd
        • Marietta Memorial Hospital
      • Marion, Ohio, Förenta staterna, 43302
        • Upphängd
        • OhioHealth Marion General Hospital
      • Mount Vernon, Ohio, Förenta staterna, 43050
        • Upphängd
        • Knox Community Hospital
      • Newark, Ohio, Förenta staterna, 43055
        • Rekrytering
        • Licking Memorial Hospital
        • Kontakt:
        • Huvudutredare:
          • Aruna C. Gowda
      • Newark, Ohio, Förenta staterna, 43055
        • Upphängd
        • Newark Radiation Oncology
      • Perrysburg, Ohio, Förenta staterna, 43551
        • Upphängd
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, Förenta staterna, 45662
        • Upphängd
        • Southern Ohio Medical Center
      • Toledo, Ohio, Förenta staterna, 43623
        • Upphängd
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Förenta staterna, 43608
        • Upphängd
        • Mercy Health - Saint Vincent Hospital
      • Westerville, Ohio, Förenta staterna, 43081
        • Upphängd
        • Saint Ann's Hospital
      • Zanesville, Ohio, Förenta staterna, 43701
        • Upphängd
        • Genesis Healthcare System Cancer Care Center
    • Oregon
      • Baker City, Oregon, Förenta staterna, 97814
        • Rekrytering
        • Saint Alphonsus Cancer Care Center-Baker City
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Clackamas, Oregon, Förenta staterna, 97015
        • Upphängd
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, Förenta staterna, 97132
        • Rekrytering
        • Providence Newberg Medical Center
        • Kontakt:
        • Huvudutredare:
          • Charles W. Drescher
      • Ontario, Oregon, Förenta staterna, 97914
        • Rekrytering
        • Saint Alphonsus Cancer Care Center-Ontario
        • Kontakt:
        • Huvudutredare:
          • Tareq Al baghdadi
      • Oregon City, Oregon, Förenta staterna, 97045
        • Rekrytering
        • Providence Willamette Falls Medical Center
        • Kontakt:
        • Huvudutredare:
          • Charles W. Drescher
      • Portland, Oregon, Förenta staterna, 97213
        • Rekrytering
        • Providence Portland Medical Center
        • Kontakt:
        • Huvudutredare:
          • Charles W. Drescher
      • Portland, Oregon, Förenta staterna, 97225
        • Rekrytering
        • Providence Saint Vincent Medical Center
        • Kontakt:
        • Huvudutredare:
          • Charles W. Drescher
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23298
        • Rekrytering
        • VCU Massey Comprehensive Cancer Center
        • Huvudutredare:
          • Bharadhwaj Kolipakkam
        • Kontakt:
    • Washington
      • Edmonds, Washington, Förenta staterna, 98026
        • Rekrytering
        • Swedish Cancer Institute-Edmonds
        • Huvudutredare:
          • Charles W. Drescher
        • Kontakt:
      • Issaquah, Washington, Förenta staterna, 98029
        • Rekrytering
        • Swedish Cancer Institute-Issaquah
        • Huvudutredare:
          • Charles W. Drescher
        • Kontakt:
      • Seattle, Washington, Förenta staterna, 98122
        • Rekrytering
        • Swedish Medical Center-First Hill
        • Huvudutredare:
          • Charles W. Drescher
        • Kontakt:
    • Wisconsin
      • Appleton, Wisconsin, Förenta staterna, 54911
        • Rekrytering
        • ThedaCare Regional Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Yazhini Vallatharasu
      • Eau Claire, Wisconsin, Förenta staterna, 54701
        • Aktiv, inte rekryterande
        • Marshfield Medical Center-EC Cancer Center
      • La Crosse, Wisconsin, Förenta staterna, 54601
        • Rekrytering
        • Gundersen Lutheran Medical Center
        • Kontakt:
        • Huvudutredare:
          • David E. Marinier
      • Marshfield, Wisconsin, Förenta staterna, 54449
        • Aktiv, inte rekryterande
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, Förenta staterna, 54548
        • Aktiv, inte rekryterande
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, Förenta staterna, 54868
        • Aktiv, inte rekryterande
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Förenta staterna, 54482
      • Weston, Wisconsin, Förenta staterna, 54476

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as determined by IgM protein quantification.

    • IgM Spike: ≥ 500 mg/dL (≥ 5 g/L)
    • Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as the lymph nodes or spleen. Note: all participants must have measurable IgM spike, but are not required to have extramedullary disease

  • Testing to establish baseline disease status must be performed within 28 days prior to registration

  • Participants must have at least one of the criteria to require therapy for WM including:

    • Anemia

    • Thrombocytopenia

    • Neuropathy related to WM

    • Symptomatic hyperviscosity or serum viscosity levels ≥ 4.0 centipoises

    • WM associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms

      • Constitutional symptoms can be described as:

        • Unintentional weight loss >= 10% within the previous 6 months prior to screening
        • Fevers higher than 100.5 degrees Fahrenheit (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without evidence of infection
        • Night sweats for more than 1 month prior to screening without evidence of infection
        • Clinically relevant fatigue which is not relieved by rest due to WM

  • Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug will be excluded from the study. If such participants can be safely switched to an alternative agent, then the participants will be eligible to enroll

  • Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration

  • Participants must be >= 18 years of age

  • Participants must have history and physical exam within 28 days prior to registration

  • Participants must have Zubrod performance status =< 2

  • Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) >= 30 mL/min. Values must be obtained within 14 days prior to registration

  • Total bilirubin =< 1.5 x IULN (institutional upper limit of the norm) (within 14 days prior to registration)

  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x IULN (within 14 days prior to registration)

  • Alkaline phosphatase =< 3 x IULN (within 14 days prior to registration)

  • Platelet count >= 50,000 cells/mm^3 (within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

  • Hemoglobin >= 7.0 g/dL (within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

  • Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 (within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

  • Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration

  • Participants must be able to take and swallow oral medication (capsules) whole. Participants may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

  • Participants must not be intolerant to rituximab

  • Participants must not have known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding localized skin and nail bed fungal infections) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) 4 weeks prior to registration

  • Participants must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). Hepatitis C virus (HCV) testing is only required if clinically indicated or if the participant has a history of HCV

  • Participants must not consume grapefruit, Seville oranges or starfruit within 3 days prior to the first dose of venetoclax

  • Participants must not be pregnant or nursing because venetoclax has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condom, cervical ring, sponge, etc.). This also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures throughout the study and for at least 30 days after competition of therapy

  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years or watchful waiting is appropriate in the opinion of the treating physician. Also, malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 5 years, is permissible consideration of eligibility for this trial

  • Participants must be offered the opportunity to participate in specimen banking

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

  • As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  • CROSSOVER CRITERIA: Participants must have been registered and received treatment in the IR/Z or VR arm and must show progression of disease at any time during cycles 3-24

  • CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome the participants will not undergo registration step 2 crossover and will be taken off the study

  • CROSSOVER CRITERIA: Participants must have Zubrod performance status =< 2

  • CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) >= 30 mL/min. Values must be obtained within 14 days prior to registration

  • CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction on any recent liver function tests within 14 days prior to registration

  • CROSSOVER CRITERIA: Platelet count >= 50,000 cells/mm^3 (without within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

  • CROSSOVER CRITERIA: Hemoglobin >= 7.0 g/dL (without within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

  • CROSSOVER CRITERIA: Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 (without within 14 days prior to registration)

    • NOTE: Transfusion and/or growth factor support is allowed up to 7 days prior to registration

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Arm I (ibrutinib + rituximab or zanubrutinib)

Patients receive ibrutinib PO QD on days 1-28 of cycles 1-24 and rituximab IV on days 1, 8, 15, and 22 of cycles 2 and 5, or zanubrutinib PO QD or BID on days 1-28 of cycles 1-24. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm I may receive rituximab and venetoclax as in Arm II for up to an additional 24 cycles. Patients undergo CT or PET/CT and bone marrow biopsy and aspiration as well as blood sample collection throughout the trial.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Biologisk: Rituximab

Given IV

Andra namn:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonal antikropp
  • Chimär anti-CD20-antikropp
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonal antikropp
  • Monoklonal antikropp IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rit
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Läkemedel: Ibrutinib

Given PO

Andra namn:
  • PCI-32765
  • Imbruvica
  • BTK-hämmare PCI-32765
  • CRA-032765
  • PCI32765
  • CRA 032765
  • CRA032765
  • PCI 32765
Procedur: Computed Tomography

Undergo CT or PET/CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Procedur: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedur: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Andra namn:
  • Biopsi av benmärg
  • Biopsi, benmärg
Läkemedel: Zanubrutinib

Given PO

Andra namn:
  • Brukinsa
  • BGB-3111
  • BTK-InhB
  • BGB 3111
  • BGB3111
Experimentell: Arm II (venetoclax, rituximab)

Patients receive venetoclax PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15, and 22 of cycles 2 and 5. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm II may receive ibrutinib and rituximab as in Arm I for up to an additional 24 cycles. Patients undergo CT or PET/CT and bone marrow biopsy and aspiration as well as blood sample collection throughout the trial.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Biologisk: Rituximab

Given IV

Andra namn:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonal antikropp
  • Chimär anti-CD20-antikropp
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonal antikropp
  • Monoklonal antikropp IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rit
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Procedur: Computed Tomography

Undergo CT or PET/CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Läkemedel: Venetoclax

Given PO

Andra namn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Procedur: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedur: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Andra namn:
  • Biopsi av benmärg
  • Biopsi, benmärg

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Very good partial response or better (VGPR or better) rate
Tidsram: Up to 5 years

A Cochran-Mantel-Haenszel test will be performed to compare the VGPR in the ibrutinib plus rituximab or zanubrutinib alone arm and the venetoclax plus rituximab arm accounting for the stratification factor of prior rituximab, and VGPR or better rate will be reported in each study arm with a binomial confidence interval.
Up to 5 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free survival
Tidsram: From the date of registration to the date of first documentation of progressive disease or symptomatic deterioration, or death due to any cause, assessed up to 5 years

Will be analyzed using the Kaplan-Meier method, and a stratified log-rank test will be performed to compare survival outcomes in the ibrutinib plus rituximab or zanubrutinib alone and venetoclax plus rituximab arms while controlling for the effects from the stratification factor of prior rituximab treatment.
From the date of registration to the date of first documentation of progressive disease or symptomatic deterioration, or death due to any cause, assessed up to 5 years
Overall survival
Tidsram: From the date of registration to the date of death due to any cause, assessed up to 5 years

Will be analyzed using the Kaplan-Meier method, and a stratified log-rank test will be performed to compare survival outcomes in the ibrutinib plus rituximab or zanubrutinib alone and venetoclax plus rituximab arms while controlling for the effects from the stratification factor of prior rituximab treatment.
From the date of registration to the date of death due to any cause, assessed up to 5 years
Rate of complete response
Tidsram: From the date of registration to the date of complete response, assessed up to 5 years

Will be analyzed using the cumulative incidence competing risks method.
From the date of registration to the date of complete response, assessed up to 5 years
Overall response rate
Tidsram: Up to 5 years

Defined as the percentage of participants achieving a best response of complete response, very good partial response, or partial response while on study. Will be reported with a binomial confidence interval.
Up to 5 years
Time to VGPR or better
Tidsram: Up to 5 years

Defined as the percentage of participants achieving a best response of very good partial response or better while on study. Will be reported with a binomial confidence interval.
Up to 5 years
Incidence of adverse events
Tidsram: Up to 5 years

As assessed by Common Terminology Criteria for Adverse Events Version 5.0.
Up to 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Sikander Ailawadhi, SWOG Cancer Research Network

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 januari 2022

Primärt slutförande (Beräknad)

31 mars 2028

Avslutad studie (Beräknad)

31 mars 2028

Studieregistreringsdatum

Först inskickad

9 april 2021

Först inskickad som uppfyllde QC-kriterierna

9 april 2021

Första postat (Faktisk)

12 april 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 oktober 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2021-02851
  • U10CA180888 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2021-02851 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • S2005 (Annan identifierare: CTEP)
  • S2005 (Annan identifierare: SWOG)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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