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Kinase Inhibitor

Ibrutinib + Venetoclax for Waldenstrom Macroglobulinemia

Phase 2

Waitlist Available

Led By Jorge J Castillo, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Participants with symptomatic hyperviscosity must undergo plasmapheresis prior to treatment initiation

Must not have

Uncontrolled intercurrent illness

Concurrent administration of warfarin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well the combination of these drugs works in treating patients with Waldenstrom macroglobulinemia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include digestive issues like nausea or constipation, low blood cell counts which can increase infection risk, fatigue, bleeding problems due to reduced clotting ability, muscle pain or bone pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have been diagnosed with Waldenström macroglobulinemia.

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I can take care of myself but might not be able to do heavy physical work.

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My condition requires treatment according to specific expert guidelines.

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My tumor has a MYD88 mutation confirmed by a certified lab.

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I am using birth control or abstaining from sex and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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I am currently taking warfarin.

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I am a male and plan to try for a child during the study or within 3 months after it ends.

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

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I have been diagnosed with lymphoma in my central nervous system.

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I have HIV or chronic hepatitis B or C needing treatment.

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I have a known bleeding disorder.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I cannot take medications by mouth due to a digestive condition.

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I cannot swallow pills.

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My liver is severely impaired (Child-Pugh class C).

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I haven't taken strong medication or certain foods that affect drug metabolism in the last week.

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I have had treatment for Waldenstrom's macroglobulinemia before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy

Secondary study objectives

Median Time to Major Response

Median Time to Response

Number of Participants With Complete Response (CR) After 12 Cycles

+11 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

0 / 20Eligibility criteria met