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NCT04840602 · ClinicalTrials.gov registry record · Phase 2
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 2 study of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 20
- Study locations
NCT04840602: Recruiting Phase 2 study of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, sponsored by National Cancer Institute (NCI).
NCT04840602 is a Phase 2 study of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, below the 471-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04840602, a Phase 2 study of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Ibrutinib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
- Mayo Clinic in Florida - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia - North Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Illinois
- Centralia Oncology Clinic - Centralia
- Carle at The Riverfront - Danville
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Carle Physician Group-Effingham - Effingham
- Crossroads Cancer Center - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Cancer Care Center of O'Fallon - O'Fallon
- Southern Illinois University School of Medicine - Springfield
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 2 |
What NCT04840602 shows while recruiting
NCT04840602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 471-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04840602 names 20 study sites across 3 states, led by Florida, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT04840602 about?
NCT04840602 is a clinical study titled "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". 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 th...
What is the current status of trial NCT04840602?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2022-01-05. Estimated completion is 2028-03-31.
What conditions does trial NCT04840602 study?
This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma.
What interventions are being tested in trial NCT04840602?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT04840602?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04840602 being conducted?
This trial has 20 study locations across Arizona, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Waldenstrom Macroglobulinemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04840602's enrollment target sits among peer trials
92 17th of 34 higher than 18 of 34 other Waldenstrom Macroglobulinemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Waldenstrom Macroglobulinemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
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Epcoritamab in Previously Treated WM
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Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia
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Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
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Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma
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