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Tyrosine Kinase Inhibitor
Ulocuplumab + Ibrutinib for Waldenstrom's Macroglobulinemia
Phase 1 & 2
Waitlist Available
Led By Steven P. Treon, MD, PhD
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
Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia (Kyle et al, 2003) or have high risk disease with a serum IgM level of 6,000 mg or higher (Gustine et al, 2016)
MYD88 and CXCR4 mutated disease (determined by Treon laboratory or molecular diagnostics laboratory)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat Waldenstrom's Macroglobulinemia, a cancer of the blood.
Who is the study for?
This trial is for adults with Waldenstrom's Macroglobulinemia who need treatment, have specific genetic mutations (MYD88 and CXCR4), measurable disease, and normal organ/marrow function. Participants must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have heart failure, HIV/HBV/HCV infections, severe ongoing toxicity from past cancer treatments or any condition that could risk their safety or affect study results.Check my eligibility
What is being tested?
The study tests a combination of Ulocuplumab and Ibrutinib as a potential therapy for symptomatic Waldenstrom's Macroglobulinemia. It aims to see how well these drugs work together in treating this blood cancer by monitoring the participants' responses to the treatment regimen.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site for Ulocuplumab, bleeding issues due to its effect on blood cells; Ibrutinib can cause diarrhea, muscle pain, rash and might increase bleeding risk. Both drugs could potentially impact liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Waldenstrom's Macroglobulinemia and need treatment.
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My condition involves MYD88 and CXCR4 mutations.
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I am 18 years old or older.
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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 blood counts and liver/kidney functions are within safe ranges.
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My blood test shows IgM levels more than twice the normal limit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Response Rate
Maximum Tolerated Dose of Ulocuplumab
Secondary outcome measures
Overall Response Rate
Time to Major Response
Time to Minor Response
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ibrutinib + UlocuplumabExperimental Treatment2 Interventions
Ibrutinib administered orally once daily
Ulocuplumab administered intravenously 2-4 times per cycle for Cycles 1-6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,935 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,501 Total Patients Enrolled
Steven P. Treon, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with ibrutinib or ulocuplumab.I am not currently using any other cancer treatments or experimental drugs.I am not on blood thinners, except for warfarin or heparin.You have a history of not following your doctor's instructions for taking medication.I am taking medication that strongly affects liver enzymes.I have been diagnosed with lymphoma in my central nervous system.I have severe side effects from cancer treatment, except for hair loss.I have been diagnosed with Waldenstrom's Macroglobulinemia and need treatment.My condition involves MYD88 and CXCR4 mutations.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My blood counts and liver/kidney functions are within safe ranges.I am not on treatment for other cancers, except skin cancer creams.I am using or will use two forms of birth control or abstain from sex during and 28 days after the study.My blood test shows IgM levels more than twice the normal limit.I have severe heart failure.I cannot swallow pills.I have a history of HIV, HBV, or HCV.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib + Ulocuplumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for participants in this clinical research?
"At this moment, recruitment for this clinical trial has been concluded. Initially posted on October 20th 2017 and last edited June 20th 2022, it is no longer accepting participants. For those looking to join a medical study related to Waldenstrom macroglobulinemia or Ulocuplumab there are 83 and 155 active trials respectively that may be of interest."
Answered by AI
Are researchers still accepting participants for this research trial?
"This research project is not presently recruiting any new participants. Initially published on October 20th 2017, the last update occured June 20th 2022. If you're seeking additional studies to take part in, there are 83 trials currently running for patients with Waldenstrom Macroglobulinemia and 155 clinical tests open to those treatment Ulocuplumab."
Answered by AI
What are the chief goals of this medical experiment?
"This two-year long trial aims to measure the Maximum Tolerated Dose of Ulocuplumab. It will also observe secondary outcomes such as Time to Minor Response (time in months until >25%-50% reduction in serum IgM from baseline), Time to Major Response (time in months until >50-90% reduction in serum IgM from baseline) and Time to Progression (time in months before experiencing a >25% increase in serum IgM from nadir)."
Answered by AI
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