Ibrutinib + Venetoclax in Untreated WM

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04273139
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • MYD88 Gene Mutation
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jul 9, 2020
Status verified
Jul 2025
Primary completion
Jun 6, 2022
Completion
Feb 1, 2028

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib and Venetoclax
    The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Ibrutinib will be administered at a predetermined dose, once daily for 28 days * TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment) * Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.

Primary Outcome Measure

Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy [ Time Frame: The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-

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By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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