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测试在华氏巨球蛋白血症/淋巴浆细胞性淋巴瘤的常规治疗(依鲁替尼和利妥昔单抗)中加入新药 Venetoclax

2026年10月29日 更新者:National Cancer Institute (NCI)

Ibrutinib 和 Rituximab 联合或不联合 Venetoclax 治疗先前未治疗的 Waldenström 巨球蛋白血症 (WM) / 淋巴浆细胞性淋巴瘤 (LPL) 的 II 期随机研究

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

92

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.

Undergo blood sample collection

其他名称:
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

Given IV

其他名称:
  • 利妥昔单抗
  • 美罗华
  • 总部基地 798
  • BI 695500
  • C2B8单克隆抗体
  • 嵌合抗 CD20 抗体
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8单克隆抗体
  • 单克隆抗体IDEC-C2B8
  • PF-05280586
  • 里亚布尼
  • 利妥昔单抗ABBS
  • 利妥昔单抗ARRX
  • 利妥昔单抗生物类似药 ABP 798
  • 利妥昔单抗生物仿制药 BI 695500
  • 利妥昔单抗生物类似药 CT-P10
  • 利妥昔单抗生物类似药 GB241
  • 利妥昔单抗生物仿制药 IBI301
  • 利妥昔单抗生物类似药 JHL1101
  • 利妥昔单抗生物仿制药 PF-05280586
  • 利妥昔单抗生物类似药 RTXM83
  • 利妥昔单抗生物仿制药 SAIT101
  • 利妥昔单抗生物仿制药 SIBP-02
  • 利妥昔单抗生物类似药 TQB2303
  • 利妥昔单抗PVVR
  • 利妥昔单抗-arrx
  • 利妥昔单抗-pvvr
  • RTXM83
  • Ruxience
  • 特鲁希玛
  • 里克松
  • 伊克达尔
  • 马布塔斯
  • 利妥昔单抗-abbs
  • BI-695500
  • BI695500
  • 闪电战
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • 里特维亚
  • 利妥昔单抗-blit
  • 利西名
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • 2013年大奖赛
  • GP-2013
  • GP2013
  • 利妥昔单抗生物仿制药 GP2013

Given PO

其他名称:
  • PCI-32765
  • 因布鲁维察
  • BTK 抑制剂 PCI-32765
  • CRA-032765
  • PCI32765
  • 加拿大税务局 032765
  • CRA032765
  • PCI 32765

Undergo CT or PET/CT

其他名称:
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描(程序)
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型

Undergo PET/CT

其他名称:
  • 医学成像、正电子发射断层扫描
  • 宠物
  • 宠物扫描
  • 正电子发射断层扫描
  • PT
  • 正电子发射断层扫描(程序)

Undergo bone marrow biopsy and aspiration

Undergo bone marrow biopsy and aspiration

其他名称:
  • 骨髓活检
  • 活组织检查,骨髓

Given PO

其他名称:
  • 布鲁金萨
  • BGB-3111
  • BTK-InhB
  • BGB 3111
  • BGB3111
实验性的: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.

Undergo blood sample collection

其他名称:
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

Given IV

其他名称:
  • 利妥昔单抗
  • 美罗华
  • 总部基地 798
  • BI 695500
  • C2B8单克隆抗体
  • 嵌合抗 CD20 抗体
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8单克隆抗体
  • 单克隆抗体IDEC-C2B8
  • PF-05280586
  • 里亚布尼
  • 利妥昔单抗ABBS
  • 利妥昔单抗ARRX
  • 利妥昔单抗生物类似药 ABP 798
  • 利妥昔单抗生物仿制药 BI 695500
  • 利妥昔单抗生物类似药 CT-P10
  • 利妥昔单抗生物类似药 GB241
  • 利妥昔单抗生物仿制药 IBI301
  • 利妥昔单抗生物类似药 JHL1101
  • 利妥昔单抗生物仿制药 PF-05280586
  • 利妥昔单抗生物类似药 RTXM83
  • 利妥昔单抗生物仿制药 SAIT101
  • 利妥昔单抗生物仿制药 SIBP-02
  • 利妥昔单抗生物类似药 TQB2303
  • 利妥昔单抗PVVR
  • 利妥昔单抗-arrx
  • 利妥昔单抗-pvvr
  • RTXM83
  • Ruxience
  • 特鲁希玛
  • 里克松
  • 伊克达尔
  • 马布塔斯
  • 利妥昔单抗-abbs
  • BI-695500
  • BI695500
  • 闪电战
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • 里特维亚
  • 利妥昔单抗-blit
  • 利西名
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • 2013年大奖赛
  • GP-2013
  • GP2013
  • 利妥昔单抗生物仿制药 GP2013

Undergo CT or PET/CT

其他名称:
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描(程序)
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型

Undergo PET/CT

其他名称:
  • 医学成像、正电子发射断层扫描
  • 宠物
  • 宠物扫描
  • 正电子发射断层扫描
  • PT
  • 正电子发射断层扫描(程序)

Given PO

其他名称:
  • 文克莱斯特
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • 文克利托
  • ABT 199
  • 游戏开发者大会 0199
  • GDC0199

Undergo bone marrow biopsy and aspiration

Undergo bone marrow biopsy and aspiration

其他名称:
  • 骨髓活检
  • 活组织检查,骨髓

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Very good partial response or better (VGPR or better) rate
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Up to 5 years

As assessed by Common Terminology Criteria for Adverse Events Version 5.0.

Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sikander Ailawadhi、SWOG Cancer Research Network

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年1月5日

初级完成 (估计的)

2028年3月31日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2021年4月9日

首先提交符合 QC 标准的

2021年4月9日

首次发布 (实际的)

2021年4月12日

研究记录更新

最后更新发布 (实际的)

2026年10月30日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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