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Kinase inhibitor

Venetoclax + Rituximab for Waldenstrom Macroglobulinemia

Phase 2

Recruiting

Led By Sikander Ailawadhi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must not have had prior systemic therapy except for rituximab at least 6 months prior to registration

Participants must have evidence of adequate renal function, total bilirubin, AST, ALT, alkaline phosphatase, platelet count, hemoglobin, and ANC within specified ranges

Must not have

Participants with impaired decision-making capabilities without legally authorized representatives

Participants with prior malignancy not meeting the specified criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at two different drug combinations for treating patients with Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. One combination includes venetoclax and

Who is the study for?

This trial is for adults with untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma who have symptoms like anemia, neuropathy, or significant weight loss. They must not be on certain drugs that affect the body's enzyme systems and should have good kidney function and acceptable blood test results.

What is being tested?

The study compares two treatments: Venetoclax with Rituximab versus the usual Ibrutinib with Rituximab. It aims to see if blocking a protein needed by cancer cells (with Venetoclax) plus helping the immune system target cancer cells (with Rituximab) is more effective than current standard treatment.

What are the potential side effects?

Potential side effects include reactions related to the immune system targeting normal cells, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, kidney dysfunction, and possibly other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had any cancer treatment except for rituximab over 6 months ago.

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My kidney function and blood tests are within normal ranges.

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I can take and swallow pills.

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I have been diagnosed with Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma with measurable disease.

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I am HIV positive, on treatment, and my viral load is undetectable.

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

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I do not have any active infections or hepatitis C.

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I have not had any other cancer types, except for certain allowed cases.

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I can tolerate rituximab without severe side effects.

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot make medical decisions and do not have a legal representative.

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I have had cancer before, but it doesn't meet the trial's specific criteria.

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My lymphoma has become more aggressive or I have Bing-Neel syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Very good partial response or better (VGPR or better) rate

Secondary study objectives

Incidence of adverse events

Overall response rate

Overall survival

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (venetoclax, rituximab)Experimental Treatment7 Interventions

Patients receive venetoclax PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15, and 22 of cycles 1 and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm II may receive ibrutinib and rituximab as in Arm I for up to an additional 24 cycles. Patients undergo CT or PET/CT and bone marrow biopsy and aspiration as well as blood sample collection during screening and on the trial.

Group II: Arm I (ibrutinib, rituximab)Active Control7 Interventions

Patients receive ibrutinib PO QD on days 1-28 of cycles 1-24 and rituximab IV on days 1, 8, 15, and 22 of cycles 1 and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease during Arm I may receive rituximab and venetoclax as in Arm II for up to an additional 24 cycles. Patients undergo CT or PET/CT and bone marrow biopsy and aspiration as well as blood sample collection during screening and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Rituximab

1999

Completed Phase 4

~2990