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Tyrosine Kinase Inhibitor
Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Nitin Jain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of CLL/SLL
Cohort 1: Refractory to and/or relapsed after at least one prior therapy will be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study Summary
This trial looks at how well two drugs work to treat patients with chronic or small lymphocytic leukemia. Venetoclax may stop cancer cell growth by blocking a protein needed for cell survival. Ibrutinib may stop cancer cell growth by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for patients with chronic or small lymphocytic leukemia who are in good physical condition (ECOG <=2) and have properly functioning kidneys and liver. It includes those untreated with high-risk features, relapsed after prior therapy, or free from other malignancies for 2 years. Pregnant women, HIV-positive individuals, those with active infections or hepatitis B/C, recent recipients of certain therapies, and anyone on strong CYP3A inhibitors/inducers can't participate.Check my eligibility
What is being tested?
The study tests the combination of venetoclax and ibrutinib to treat chronic/small lymphocytic leukemia. Venetoclax aims to block a protein that cancer cells need to survive while Ibrutinib targets enzymes important for cell growth. The goal is to see if this drug combo can control the disease better than current treatments.See study design
What are the potential side effects?
Potential side effects include digestive issues like nausea or diarrhea; low blood counts leading to increased infection risk; fatigue; possible liver function changes; allergic reactions; bleeding problems due to low platelets; muscle and bone pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL/SLL.
Select...
My condition did not improve after at least one treatment.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My kidneys work well enough to clear at least 50 mL/min of creatinine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response (complete response /complete response with incomplete recovery) of combined ibrutinib and venetoclax
Secondary outcome measures
Complete response/complete response with incomplete recovery rate in each subgroups of patients
Incidence of toxicities
Overall survival
+2 moreOther outcome measures
Changes in immunological biomarkers
Body Weight Changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib, venetoclax)Experimental Treatment3 Interventions
Patients receive ibrutinib PO QD on days 1-28. Beginning on day 1 of cycle 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for MRD after cycle 27 may continue treatment with ibrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,547 Total Patients Enrolled
Nitin JainPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
355 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive and understand there may be interactions with my medication.I have been diagnosed with CLL/SLL.My condition did not improve after at least one treatment.I do not have an active hepatitis B infection, or I am vaccinated against it.I do not have serious heart problems like uncontrolled heart rhythm issues or recent heart attacks.I have been treated with venetoclax or ibrutinib before.I cannot take medications by mouth due to a digestive condition.I have an active autoimmune condition needing high-dose steroids.I have not taken strong CYP3A inhibitors or inducers in the last 7 days.I am over 65 or have specific genetic markers and need treatment for my CLL.I can take care of myself and am up and about more than half of the day.My platelet count is above 20,000 without recent transfusions, unless it's due to my disease.I am not pregnant or have taken steps to prevent pregnancy during the study.I haven't had cancer, except for certain skin cancers or early-stage cervical or breast cancer, in the last 2 years.I haven't had major treatments or experimental drugs for my condition in the last 3 weeks.I do not have an untreated ongoing infection.My kidneys work well enough to clear at least 50 mL/min of creatinine.I have active hepatitis C confirmed by a specific blood test.I am currently taking warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, venetoclax)
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 positions available for test subjects?
"The clinical trial mentioned is not presently looking for patients, as seen on clinicaltrials.gov. The study was originally posted on 7/7/2016 and was most recently updated on 10/12/2022; however, there are 4180 other trials currently searching for participants at this time."
Answered by AI
Could you please review other instances where Ibrutinib has been used in medical research?
"There are currently 352 clinical trials researching Ibrutinib with 46 in Phase 3. Most of these medical studies are based in Edmonton, Alberta; however, there are 11772 locations running trials for Ibrutinib worldwide."
Answered by AI
What are the main disorders that ibrutinib has been found to be an effective treatment for?
"Ibrutinib is an effective at treating three distinct blood cancers: waldenstrom macroglobulinemia, small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."
Answered by AI
How many people total are participating in this experiment?
"As of October 12th, 2022, this trial is no longer recruiting patients. It was initially posted on July 7th, 2016. If you are interested in other trials, 3828 studies are actively looking for patients experiencing relapse and 352 studies are seeking Ibrutinib candidates."
Answered by AI
Is it safe to take Ibrutinib?
"Although there is some data supporting Ibrutinib's safety, it is still classified as a Phase 2 drug. This means that while its safety has been studied, there is no evidence yet of the medication being effective."
Answered by AI
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