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RECRUITING 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

NCT04840602 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 92 participants
Start Date 2022-01-05
Est. Completion 2028-03-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04840602

The ClinicalTrials.gov registry entry for NCT04840602 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04840602 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04840602?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial