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Waldenstrom의 마크로글로불린혈증/림프형질세포성 림프종에 대한 일반적인 치료(Ibrutinib 및 Rituximab)에 대한 신약인 Venetoclax의 추가 테스트

2026년 10월 29일 업데이트: National Cancer Institute (NCI)

이전에 치료받지 않은 Waldenström의 마크로글로불린혈증(WM)/림프형질세포림프종(LPL)에서 Venetoclax를 병용하거나 병용하지 않은 Ibrutinib 및 Rituximab의 제2상 무작위 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

92

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
생물학적: Rituximab

Given IV

다른 이름들:
  • 리툭산
  • 맙테라
  • ABP 798
  • BI 695500
  • C2B8 단클론항체
  • 키메라 항-CD20 항체
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 단클론항체
  • 단클론항체 IDEC-C2B8
  • PF-05280586
  • 리아브니
  • 리툭시맙 ABBS
  • 리툭시맙 ARRX
  • 리툭시맙 바이오시밀러 ABP 798
  • 리툭시맙 바이오시밀러 BI 695500
  • 리툭시맙 바이오시밀러 CT-P10
  • 리툭시맙 바이오시밀러 GB241
  • 리툭시맙 바이오시밀러 IBI301
  • 리툭시맙 바이오시밀러 JHL1101
  • 리툭시맙 바이오시밀러 PF-05280586
  • 리툭시맙 바이오시밀러 RTXM83
  • 리툭시맙 바이오시밀러 SAIT101
  • 리툭시맙 바이오시밀러 SIBP-02
  • 리툭시맙 바이오시밀러 TQB2303
  • 리툭시맙 PVVR
  • 리툭시맙-arrx
  • 리툭시맙-pvvr
  • RTXM83
  • 루시언스
  • 트룩시마
  • 릭사톤
  • 익다르
  • 맘타스
  • 리툭시맙-abbs
  • BI-695500
  • BI695500
  • 블리치마
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • 리템비아
  • 리툭시맙-블릿
  • 리툭시맙-라이트
  • 리툭시맙-릭사
  • 리툭시맙-릭시
  • 리치묘
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • 리툭시맙 바이오시밀러 GP2013
의약품: Ibrutinib

Given PO

다른 이름들:
  • PCI-32765
  • 임브루비카
  • BTK 억제제 PCI-32765
  • CRA-032765
  • PCI32765
  • CRA 032765
  • CRA032765
  • PCI 32765
절차: Computed Tomography

Undergo CT or PET/CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Positron Emission Tomography

Undergo PET/CT

다른 이름들:
  • 의료 영상, 양전자 방출 단층 촬영
  • 애완 동물
  • PET 스캔
  • 양전자 방출 단층 촬영 스캔
  • 양전자 방출 단층 촬영
  • PT
  • 양전자방출단층촬영(시술)
절차: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

절차: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

다른 이름들:
  • 골수 생검
  • 생검, 골수
의약품: Zanubrutinib

Given PO

다른 이름들:
  • 브루킨사
  • BGB-3111
  • BTK-InhB
  • BGB 3111
  • BGB3111
실험적: 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.
절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
생물학적: Rituximab

Given IV

다른 이름들:
  • 리툭산
  • 맙테라
  • ABP 798
  • BI 695500
  • C2B8 단클론항체
  • 키메라 항-CD20 항체
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 단클론항체
  • 단클론항체 IDEC-C2B8
  • PF-05280586
  • 리아브니
  • 리툭시맙 ABBS
  • 리툭시맙 ARRX
  • 리툭시맙 바이오시밀러 ABP 798
  • 리툭시맙 바이오시밀러 BI 695500
  • 리툭시맙 바이오시밀러 CT-P10
  • 리툭시맙 바이오시밀러 GB241
  • 리툭시맙 바이오시밀러 IBI301
  • 리툭시맙 바이오시밀러 JHL1101
  • 리툭시맙 바이오시밀러 PF-05280586
  • 리툭시맙 바이오시밀러 RTXM83
  • 리툭시맙 바이오시밀러 SAIT101
  • 리툭시맙 바이오시밀러 SIBP-02
  • 리툭시맙 바이오시밀러 TQB2303
  • 리툭시맙 PVVR
  • 리툭시맙-arrx
  • 리툭시맙-pvvr
  • RTXM83
  • 루시언스
  • 트룩시마
  • 릭사톤
  • 익다르
  • 맘타스
  • 리툭시맙-abbs
  • BI-695500
  • BI695500
  • 블리치마
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • 리템비아
  • 리툭시맙-블릿
  • 리툭시맙-라이트
  • 리툭시맙-릭사
  • 리툭시맙-릭시
  • 리치묘
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • 리툭시맙 바이오시밀러 GP2013
절차: Computed Tomography

Undergo CT or PET/CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Positron Emission Tomography

Undergo PET/CT

다른 이름들:
  • 의료 영상, 양전자 방출 단층 촬영
  • 애완 동물
  • PET 스캔
  • 양전자 방출 단층 촬영 스캔
  • 양전자 방출 단층 촬영
  • PT
  • 양전자방출단층촬영(시술)
의약품: Venetoclax

Given PO

다른 이름들:
  • 벤클렉스타
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • 벤클릭스토
  • ABT 199
  • GDC 0199
  • GDC0199
절차: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

절차: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

다른 이름들:
  • 골수 생검
  • 생검, 골수

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Very good partial response or better (VGPR or better) rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free survival
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 5 years

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Sikander Ailawadhi, SWOG Cancer Research Network

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 1월 5일

기본 완료 (추정된)

2028년 3월 31일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2021년 4월 9일

QC 기준을 충족하는 최초 제출

2021년 4월 9일

처음 게시됨 (실제)

2021년 4월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2021-02851
  • U10CA180888 (미국 NIH 보조금/계약)
  • NCI-2021-02851 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • S2005 (기타 식별자: CTEP)
  • S2005 (기타 식별자: SWOG)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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