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Kinase inhibitor

Ibrutinib 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Very good partial response or better (VGPR or better) rate
Secondary outcome measures
Incidence of adverse events
Overall response rate
Overall survival
+3 more

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
2008
Completed Phase 2
~2240
Rituximab
1999
Completed Phase 4
~1880
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Biospecimen Collection
2004
Completed Phase 2
~1700
Venetoclax
2019
Completed Phase 3
~1990
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,349 Total Patients Enrolled
137 Trials studying Waldenstrom Macroglobulinemia
8,668 Patients Enrolled for Waldenstrom Macroglobulinemia
Sikander AilawadhiPrincipal InvestigatorSWOG Cancer Research Network
7 Previous Clinical Trials
4,064 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
2022. "Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840602.
All > Waldenstrom Macroglobulinemia
~58 spots leftby Mar 2028
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