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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of time from start of treatment to time of death or last follow-up up to 72 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of time from start of treatment to time of death or last follow-up up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of time from start of treatment to time of death or last follow-up up to 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Very Good Partial Response (VGPR)
Secondary outcome measures
Impact of IVEN in the participants' quality of life
Impact ofCXCR4 mutations on overall response
Median time to major response
+11 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Rhinovirus infection
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ibrutinib and Venetoclax (3 dose ramp up)Experimental Treatment2 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
First 12 participants
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.
Group II: Ibrutinib and Venetoclax (2 dose ramp up)Experimental 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 schedule during cycle 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,822 Total Patients Enrolled
28 Trials studying Waldenstrom Macroglobulinemia
2,724 Patients Enrolled for Waldenstrom Macroglobulinemia
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,055 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
113 Patients Enrolled for Waldenstrom Macroglobulinemia
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,770 Total Patients Enrolled
5 Trials studying Waldenstrom Macroglobulinemia
1,159 Patients Enrolled for Waldenstrom Macroglobulinemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not have any uncontrolled illnesses.I have not had major surgery in the last 4 weeks.I am currently taking warfarin.I am a male and plan to try for a child during the study or within 3 months after it ends.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.I finished treatment for an infection less than 14 days ago.I have been diagnosed with Waldenström macroglobulinemia.I have not had a stroke or brain bleed in the last 6 months.I have not received any live vaccines in the last 4 weeks.I am not on active treatment for other cancers, except for skin cancer creams.I have been diagnosed with lymphoma in my central nervous system.I can take care of myself but might not be able to do heavy physical work.My organ and bone marrow functions are within normal ranges.My condition requires treatment according to specific expert guidelines.I have HIV or chronic hepatitis B or C needing treatment.I have a known bleeding disorder.You have a high level of a specific protein in your blood called immunoglobin M (IgM).You have a history of not following your doctor's instructions for taking medications.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I cannot take medications by mouth due to a digestive condition.I am willing and able to follow the study's requirements.My tumor has a MYD88 mutation confirmed by a certified lab.You have a history of alcohol or drug abuse.I cannot swallow pills.I am using birth control or abstaining from sex and have a negative pregnancy test.My liver is severely impaired (Child-Pugh class C).I haven't taken strong medication or certain foods that affect drug metabolism in the last week.I have had treatment for Waldenstrom's macroglobulinemia before.I haven't taken immunosuppressants in the last 21 days.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib and Venetoclax (3 dose ramp up)
- Group 2: Ibrutinib and Venetoclax (2 dose ramp up)
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.
Are there any records of prior experimentation with Venetoclax?
"Presently, there are 343 active clinical trials related to Venetoclax. Of those, 45 have reached the third phase of testing. Most research is based in Edmonton but there are 11,699 separate sites for these studies across the globe."
Answered by AI
What precautionary measures should be taken when administering Venetoclax to individuals?
"We assessed the safety of Venetoclax to be a 2 on our 1-3 scale; this is because Phase 2 trials have some evidence supporting safety but lack data concerning efficacy."
Answered by AI
Are there any vacancies still available for participants in this experiment?
"Unfortunately, this trial is not currently seeking participants. It was first posted on the 24th June 2020 and last updated on 2nd November 2022. For those looking for other clinical trials related to waldenstrom macroglobulinemia, there are 85 studies admitting patients at present; alternatively, Venetoclax has 343 trials actively enrolling individuals."
Answered by AI
How many participants have thus far committed to this research program?
"This research project is no longer accepting participants. It was first posted on June 24th 2020 and last modified November 2nd 2022. Alternatives can be found in the form of 85 studies admitting patients with waldenstrom macroglobulinemia, as well as 343 clinical trials involving Venetoclax that are presently enrolling candidates."
Answered by AI
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