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Kinase Inhibitor
Ibrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Matthew Davids, MD, MMSc
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
- ECOG Performance Status <2
Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma as per IW-CLL 2008 criteria and require therapy based on meeting at least one of the following criteria:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combo therapy for Chronic Lymphocytic Leukemia (CLL).
Who is the study for?
Adults diagnosed with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who need treatment and have previously had therapy that didn't work. They must not be pregnant, agree to use contraception, and should not have severe allergies to monoclonal antibodies or a history of certain other cancers. Major organ functions must meet specific criteria, and they can't join if they've recently had surgery, infections requiring systemic treatment, heart issues, or are on strong CYP3A inhibitors.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two drugs: Ibrutinib and Obinutuzumab in treating Chronic Lymphocytic Leukemia (CLL). Participants will receive both medications as part of their treatment regimen to see how well they work together against CLL.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to infusion treatments, liver problems indicated by changes in enzyme levels, fatigue due to anemia or low blood counts from bone marrow involvement. There's also a risk for infection because the immune system may be weakened.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities without help.
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I have been diagnosed with CLL or SLL and need treatment.
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My blood tests show low hemoglobin or platelets.
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My spleen is very large, growing, or causing symptoms.
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I have lost more than 10% of my weight without trying in the last 6 months.
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I have had significant fatigue and fevers over 100.5°F without infection for 2+ weeks.
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My white blood cell count is at a safe level for treatment.
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I have had night sweats for over a month without being sick.
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My lymph nodes are very large, growing, or causing symptoms.
Select...
My CLL has not responded or has come back after treatment.
Select...
I am 18 years old or older.
Select...
My autoimmune anemia or thrombocytopenia does not respond well to steroids.
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
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary outcome measures
Complete Response Rate
Duration of Response
Minimal residual disease (MRD) status in the bone marrow and blood
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Arm C- obinutuzumab/ibrutinibExperimental Treatment2 Interventions
Participants enrolled in Arm C will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. At the same time, participants will begin to receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6.
Group II: Arm B- ibrutinib -> obinutuzumabExperimental Treatment2 Interventions
Participants enrolled in Arm B will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. Participants will begin to receive obinutuzumab weekly starting cycle 2, and will receive obinutuzumab monthly during cycles 3-7
Group III: Arm A- obinutuzumab -> ibrutinibExperimental Treatment2 Interventions
Participants enrolled in Arm A will receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6. Participants will begin to take ibrutinib daily starting cycle 2 and will continue with daily ibrutinib until the end of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,818 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,635 Total Patients Enrolled
Matthew Davids, MD, MMScPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was a different type.My prostate cancer is low-risk and I am being actively monitored.I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.I finished treatment for an infection less than a week ago.I can do most of my daily activities without help.My blood test results meet the study's requirements, unless my bone marrow biopsy shows significant leukemia involvement.I had a bone marrow transplant more than 6 months ago.I have lost more than 10% of my weight without trying in the last 6 months.I have a bleeding disorder or hemophilia.I do not have HIV, active hepatitis C, or active hepatitis B.I have not had major surgery in the last 4 weeks.I do not have severe heart problems or recent major heart events.I have been diagnosed with CLL or SLL and need treatment.My blood tests show low hemoglobin or platelets.My spleen is very large, growing, or causing symptoms.I have had significant fatigue and fevers over 100.5°F without infection for 2+ weeks.My white blood cell count is at a safe level for treatment.My liver tests are within the required range.My kidney function is normal, or if not, it's due to my leukemia.My cancer has spread to my brain or spinal cord.I have not received any live vaccines in the last 4 weeks.I need warfarin or similar drugs for blood thinning.I had skin cancer (not melanoma) treated and currently show no signs of it.I have had night sweats for over a month without being sick.I do not have any ongoing infections that aren’t under control.I agree to use birth control during the study.I experience significant symptoms like fever or weight loss.You cannot be taking any other experimental medications for other studies.My lymph nodes are very large, growing, or causing symptoms.My CLL has not responded or has come back after treatment.I have been treated with obinutuzumab or ibrutinib before.You have had serious allergic reactions to treatments involving monoclonal antibodies in the past.My early-stage cancer was treated successfully with no signs of disease.My cancer was treated with the goal of cure, and I've been cancer-free for over 3 years.I am not taking strong drugs that affect liver enzymes.I am 18 years old or older.My autoimmune anemia or thrombocytopenia does not respond well to steroids.I have not had a stroke or brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A- obinutuzumab -> ibrutinib
- Group 2: Arm B- ibrutinib -> obinutuzumab
- Group 3: Arm C- obinutuzumab/ibrutinib
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.
In what medical situations is Ibrutinib typically utilized?
"Ibrutinib has proven to be a successful treatment for Waldenstrom macroglobulinemia, refractory follicular lymphoma, and Chronic lymphocytic leukemia."
Answered by AI
Is enrollment still open for the participants of this trial?
"Per the information found on clinicaltrials.gov, this particular research project is no longer accepting volunteers, as it was initially posted December 1st 2015 and last updated September 28th 2022. Yet there are still 1760 other trials with ongoing recruitment at present."
Answered by AI
Has the United States Food and Drug Administration approved Ibrutinib for use?
"The clinical safety score for Ibrutinib was rated at a 1, due to the lack of information we have on its effectiveness and any potential risks associated with it."
Answered by AI
How many participants are partaking in this clinical experiment?
"Unfortunately, this trial is no longer open for recruitment. It was first posted on December 1st 2015 and last modified on September 28th 2022. However, there are currently 1523 clinical trials actively enrolling patients with leukemia, lymphocytic, chronic B-cell who may be interested in participating in a study; additionally there are 237 studies enlisting volunteers that use the drug Ibrutinib."
Answered by AI
Are there any prior investigations on Ibrutinib that could inform this research?
"The National Institutes of Health Clinical Center, 9000 Rockville Pike was the first to investigate ibrutinib in 2011. Since then, 145 trials have been completed and 237 ongoing ones are being conducted primarily in Boston, Massachusetts."
Answered by AI
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