NCT04273139

Ibrutinib + Venetoclax in Untreated WM

Phase II Study on the Combination of Ibrutinib and Venetoclax in Treatment naïve Patients With Waldenström Macroglobulinemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

* This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. * The names of the study drugs involved in this study are: * Venetoclax * ibrutinib * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will be on the research study for up to 2 years on combined venetoclax and ibrutinib and 4 years of follow-up . * It is expected that about 50 people will take part in this research study. * The U.S. Food and Drug Administration (FDA) has not approved venetoclax for your specific disease but it has been approved for other uses. \-- Venetoclax is a targeted therapy that blocks BCL-2, a protein that is important for the survival of WM cells. Laboratory studies and early clinical data have shown that the investigational new agent, venetoclax, may kill cancer cells and may cause tumors to shrink. * The U.S. Food and Drug Administration (FDA) has approved ibrutinib as a treatment option for this disease. --Ibrutinib is a targeted therapy that blocks BTK. It has been FDA approved in chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic graft vs. host disease (cGVHD), and Waldenstrom's macroglobulinemia (WM). It is also used in research studies in participants with recurrent B-cell lymphoma), diffuse large B-cell lymphoma (DLBCL), and prolymphocytic leukemia. In a study of ibrutinib in relapsed/refractory WM patients, response rates were high and the treatment was well tolerated. * The U.S. Food and Drug Administration (FDA) has not approved the combination of ibrutinib and venetoclax as a treatment for any disease. * The U.S. Food and Drug Administration (FDA) has not approved the MYD88 test. This test is investigational.

Conditions

• Waldenstrom Macroglobulinemia
• MYD88 Gene Mutation

Interventions

Type	Name	Description
DRUG	IBRUTINIB	Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
DRUG	Venetoclax	Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.

Timeline

• Start date: 2020-07-09
• Primary completion: 2022-06-06
• Completion: 2028-02-01
• First posted: 2020-02-17
• Last updated: 2025-07-30
• Results posted: 2024-04-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study