Ibrutinib + Venetoclax in Untreated WM
NCT04273139 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-11
Summary
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
Conditions
- Waldenstrom Macroglobulinemia
- MYD88 Gene Mutation
Interventions
- DRUG
-
Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
- DRUG
-
Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Pharmacyclics LLC.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Jorge J Castillo, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-09
- Primary Completion
- 2022-06-06
- Completion
- 2028-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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