RecruitingPhase 2NCT04840602

Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)


Sponsor

National Cancer Institute (NCI)

Enrollment

92 participants

Start Date

Jan 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new combination of venetoclax and rituximab against the current standard treatments (ibrutinib plus rituximab, or zanubrutinib alone) for people newly diagnosed with Waldenstrom's macroglobulinemia — a rare, slow-growing blood cancer. **You may be eligible if:** - You have a confirmed diagnosis of Waldenstrom's macroglobulinemia with measurable disease in your blood - You have symptoms that require treatment, such as anemia, low platelets, nerve problems, thick blood, or other complications from the disease - You have not previously received systemic treatment (prior rituximab is allowed if given at least 6 months ago) - You are 18 or older and in reasonably good health - Your kidney, liver, and blood counts meet minimum requirements **You may NOT be eligible if:** - You have already received chemotherapy for this condition - You are intolerant to rituximab - You have active serious infections, uncontrolled hepatitis C, or active hepatitis B - You are pregnant or breastfeeding - You cannot swallow oral capsules Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGIbrutinib

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRituximab

Given IV

DRUGVenetoclax

Given PO

DRUGZanubrutinib

Given PO


Locations(125)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Glens Falls Hospital

Glens Falls, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Levine Cancer Institute-Gaston

Gastonia, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Mount Carmel Health Center West

Columbus, Ohio, United States

Doctors Hospital

Columbus, Ohio, United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Grady Memorial Hospital

Delaware, Ohio, United States

Dublin Methodist Hospital

Dublin, Ohio, United States

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, United States

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

Saint Rita's Medical Center

Lima, Ohio, United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

OhioHealth Marion General Hospital

Marion, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Newark Radiation Oncology

Newark, Ohio, United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Mercy Health - Saint Vincent Hospital

Toledo, Ohio, United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04840602


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