Ibrutinib + Venetoclax in Untreated WM

Running, not enrolling · Phase 2

Conditions studied: Waldenstrom Macroglobulinemia, MYD88 Gene Mutation

In brief

This study evaluates the safety and efficacy of Ibrutinib combined with Venetoclax (IVEN) in the treatment of adults diagnosed with Waldenstrom's macroglobulinemia (WM) cancer with a specific MYD88 gene mutation. This research study involves an experimental drug combination of targeted therapies. The names of the study drugs involved in this study are: * Venetoclax * ibrutinib

Key facts

Study ID

NCT04273139

Run by

Dana-Farber Cancer Institute

People needed

45

Starts

2020-07-09

Expected to finish

2028-02-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet the following criteria on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy \& aspirate, and CT C/A/P will be done within 90 days prior to Cycle 1 Day 1.
• Clinicopathological diagnosis of Waldenström macroglobulinemia [28].
• Known tumor expression of mutated MYD88 performed by a CLIA certified laboratory.
• Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia [29].
• Participants with symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
• Age ≥ 18 years
• ECOG performance status ≤2 (see Appendix A)
• Measurable disease, defined as presence of serum immunoglobin M (IgM) with a minimum IgM level of >2 times the upper limit of normal of each institution is required
• At the time of screening, participants must have acceptable organ and marrow function as defined below:
• Absolute neutrophil count ≥500/uL (no growth factor permitted)
• Platelets ≥50,000/uL (no platelet transfusions permitted)
• Hemoglobin ≥ 7 g/dL (transfusions permitted)
• Total bilirubin < 1.5 x institutional ULN
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
• Estimated GFR ≥30 mL/min
• Females of childbearing potential (FCBP) must use one reliable form of contraception or have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 90 days after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed. FCBP must have a negative serum pregnancy test at screening.
• Men must agree to use a latex condom during treatment and for up to 90 days after the last dose of ibrutinib or venetoclax during sexual contact with a FCBP
• Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria
• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
• Participants who have one or more prior systemic therapies for WM.
• Participants who are receiving any other investigational agents.
• Participants with known CNS lymphoma.
• Participants with known history of Human Immunodeficiency Virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring active treatment. Note: Participants with serologic evidence of prior vaccination to HBV (i.e., HBs Ag-, and anti-HBs+ and anti-HBC-) and positive anti-HBc from IVIG may participate.
• Concurrent administration of medications or foods that are moderate or strong inhibitors or inducers of CYP3A within 7 days prior to first dose of study drug.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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