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Kinase inhibitor
Venetoclax + Ibrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 3
Waitlist Available
Led By Jennifer A Woyach
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
Age >= 65 years
If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing a new anti-cancer drug (venetoclax) to see if it can help treat patients with chronic lymphocytic leukemia who have not received previous treatment. The drug is being added to the usual treatment of ibrutinib and obinutuzumab. The trial will also investigate whether patients who receive all three treatments and have no detectable chronic lymphocytic leukemia after one year of treatment, can stop taking ibrutinib.
Who is the study for?
This trial is for older patients (65+) with untreated chronic lymphocytic leukemia who meet specific health criteria, such as certain blood cell counts and organ function. They must not have had previous CLL treatments except for steroids or rituximab for autoimmune complications, and they should be able to swallow pills without significant gastrointestinal issues.Check my eligibility
What is being tested?
The study tests adding Venetoclax, a BCL-2 inhibitor that may block cancer cell survival proteins, to the usual treatment of Ibrutinib and Obinutuzumab in treating CLL. It will also explore if patients can stop taking Ibrutinib after one year if no detectable CLL remains.See study design
What are the potential side effects?
Potential side effects include risk of infection due to immune system changes, possible liver enzyme alterations leading to liver issues, fatigue, digestive problems like nausea or constipation from Venetoclax; infusion reactions from Obinutuzumab; bleeding or bruising due to low platelet count.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
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I had hepatitis C but have been treated and now have no detectable virus.
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My condition is intermediate risk with enlarged lymph nodes or liver/spleen but no anemia or low platelets.
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My CLL or SLL is at an intermediate or high-risk stage.
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My blood tests show I have a high number of B lymphocytes.
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My spleen is very large, growing, or causing symptoms.
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You have chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and meet at least one of the following criteria: anemia or low platelet count, enlarged spleen or lymph nodes, rapidly increasing lymphocyte count, autoimmune complications, or symptoms such as weight loss, fatigue, fever, or night sweats. You have completed treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL/SLL at least 4 weeks before enrollment. You must also meet certain medical requirements, including age, performance status, blood count, kidney and liver function, and ability to swallow capsules. If you have hepatitis B or C, your viral load must be undetectable, and if you have HIV, you must have undetectable viral load within the last 6 months. You must also be able to receive medication to prevent/treat tumor lysis syndrome. Additionally, you must have completed treatment through cycle 14 day 28, have central bone marrow minimal residual disease (MRD) results, and have completed response assessment with complete response determination to be eligible for re-registration.
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My lymph nodes are very large or getting worse.
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My hepatitis B is under control with undetectable viral load on treatment.
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I have been diagnosed with CLL or SLL according to the 2018 IWCLL criteria.
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I have high-risk health issues including an enlarged spleen, low hemoglobin, or low platelets not caused by autoimmune conditions.
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I have had night sweats for over a month without any infection.
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I meet the 2018 IWCLL guidelines for treatment.
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I have an autoimmune blood condition that doesn’t respond well to standard treatments.
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My cancer affects areas outside of the lymph nodes, like skin or lungs.
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I have lost 10% or more of my weight without trying in the last 6 months.
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My kidneys are functioning well enough to clear waste.
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I can swallow pills and don't have major issues with my stomach or intestines that affect food absorption.
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I am able to get out of my bed or chair and move around.
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I have had a FISH blood test for study enrollment.
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I have worsening anemia or low platelets not caused by an autoimmune condition.
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I have had a fever over 100.5°F for more than 2 weeks without an infection.
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I have been diagnosed with CLL or SLL based on my B-cell count and symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Bone marrow (BM) minimal residual disease (MRD)- complete response (CR) rate
Incidence of adverse events
Overall survival (OS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (ibrutinib, obinutuzumab, venetoclax)Experimental Treatment4 Interventions
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.
Group II: Arm I (ibrutinib, obinutuzumab)Active Control2 Interventions
Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,699 Total Patients Enrolled
Jennifer A WoyachPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
547 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I had hepatitis C but have been treated and now have no detectable virus.My condition is intermediate risk with enlarged lymph nodes or liver/spleen but no anemia or low platelets.I am not taking, or have stopped taking, strong CYP3A4/5 inducers for the last 14 days.I finished treatment with rituximab or high dose steroids for CLL/SLL complications over 4 weeks ago.My white blood cell count is healthy, not due to bone marrow issues.My CLL or SLL is at an intermediate or high-risk stage.My blood tests show I have a high number of B lymphocytes.I have never had Richter's transformation or prolymphocytic leukemia.My spleen is very large, growing, or causing symptoms.I have not received treatment for CLL/SLL, except for steroids or specific autoimmune treatments.You have chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and meet at least one of the following criteria: anemia or low platelet count, enlarged spleen or lymph nodes, rapidly increasing lymphocyte count, autoimmune complications, or symptoms such as weight loss, fatigue, fever, or night sweats. You have completed treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL/SLL at least 4 weeks before enrollment. You must also meet certain medical requirements, including age, performance status, blood count, kidney and liver function, and ability to swallow capsules. If you have hepatitis B or C, your viral load must be undetectable, and if you have HIV, you must have undetectable viral load within the last 6 months. You must also be able to receive medication to prevent/treat tumor lysis syndrome. Additionally, you must have completed treatment through cycle 14 day 28, have central bone marrow minimal residual disease (MRD) results, and have completed response assessment with complete response determination to be eligible for re-registration.My lymph nodes are very large or getting worse.My hepatitis B is under control with undetectable viral load on treatment.I have been diagnosed with CLL or SLL according to the 2018 IWCLL criteria.I have high-risk health issues including an enlarged spleen, low hemoglobin, or low platelets not caused by autoimmune conditions.I can take medication to prevent or treat tumor lysis syndrome.I have had night sweats for over a month without any infection.I have not had a heart attack, brain bleed, or stroke in the last 6 months.I meet the 2018 IWCLL guidelines for treatment.I am on IVIG therapy but do not have active hepatitis B.You cannot have a known allergy to mannitol.I take 20 mg or less of prednisone or a similar steroid daily.I do not have an ongoing infection that needs IV antibiotics.You cannot have had a serious allergic reaction to rituximab, except for reactions that occur during the infusion process.I must provide a blood sample for a FISH test before I can join the trial.I have an autoimmune blood condition that doesn’t respond well to standard treatments.My cancer affects areas outside of the lymph nodes, like skin or lungs.I have lost 10% or more of my weight without trying in the last 6 months.My kidneys are functioning well enough to clear waste.I am HIV positive, on treatment, and my viral load is undetectable.I do not have severe heart failure, unstable chest pain, or uncontrolled irregular heartbeat.I can swallow pills and don't have major issues with my stomach or intestines that affect food absorption.I am able to get out of my bed or chair and move around.I haven't had major surgery in the last 10 days or minor surgery in the last 7 days.I have had a FISH blood test for study enrollment.My cancer cells show specific markers (CD19, CD20, CD5) without certain genetic changes.I have worsening anemia or low platelets not caused by an autoimmune condition.I have had a fever over 100.5°F for more than 2 weeks without an infection.I am not taking strong CYP3A4/5 inhibitors, or I can stop them 14 days before the study.I often feel very tired.I am not on heparin or warfarin, or I can stop warfarin 10 days before the study.I have been diagnosed with CLL or SLL based on my B-cell count and symptoms.I experience significant symptoms due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (ibrutinib, obinutuzumab, venetoclax)
- Group 2: Arm I (ibrutinib, obinutuzumab)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT03737981 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why is it common for patients to be placed under Observation?
"Observation is a common course of treatment for small lymphocytic lymphoma, but it can also help manage waldenstrom macroglobulinemia, refractory follicular lymphoma, and other blood cancers."
Answered by AI
Is enrollment still available for volunteers?
"Unfortunately, this particular clinical trial is no longer recruiting patients. If you're looking for similar studies, there are 1575 trials actively recruiting leukemia patients and 412 observation studies with open recruitment at the moment."
Answered by AI
Are there other scientific research studies that use a similar methodology to the one being proposed?
"At the moment, there are 412 on-going clinical trials concerning Observation. Out of these, 53 are in Phase 3. While a large quantity of the trials for Observation originated in Edmonton, Alberta, there are 13149 locations where these types of studies are conducted."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Loyola University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I want to see what is best medication to go with.
PatientReceived 2+ prior treatments
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