Ibrutinib + Venetoclax for Waldenstrom Macroglobulinemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJorge J Castillo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

Adults with Waldenstrom's macroglobulinemia (WM) and MYD88 gene mutation can join this trial. They must have measurable disease, be over 18, in stable health (ECOG ≤2), and have proper organ function. Women of childbearing age must use contraception or abstain from sex and not be pregnant or breastfeeding. Men must also agree to use condoms. People who've had prior WM treatments, uncontrolled illnesses, certain infections or liver diseases, or are non-compliant with medical regimens cannot participate.

Inclusion Criteria

I am 18 years old or older.

I have undergone plasmapheresis for my symptomatic hyperviscosity before starting treatment.

I am a man and agree to use a condom for 90 days after my last dose of treatment.

+9 more

Exclusion Criteria

I do not have any uncontrolled illnesses.

I have not had major surgery in the last 4 weeks.

I am currently taking warfarin.

+19 more

Participant Groups

The trial is testing the combination of two drugs: Ibrutinib and Venetoclax for untreated WM patients with a specific gene mutation. It aims to see how safe this combo is and how well it works as a treatment option.

1Treatment groups

Experimental Treatment

Group I: Ibrutinib and VenetoclaxExperimental Treatment2 Interventions

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.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: