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BTK Inhibitor
Acalabrutinib + Venetoclax ± Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By William G Wierda
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
Cohort 2: Relapsed after and/or refractory to at least one prior therapy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year end of cycle 14; each cycle 28 days
Awards & highlights
Study Summary
This trial is testing a new combination therapy for leukemia/lymphoma that has returned or is resistant to treatment. The new therapy includes a targeted drug and an immunotherapy drug.
Who is the study for?
This trial is for adults with high risk, recurrent, or treatment-resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Participants must have proper liver function, no recent malignancies (with some exceptions), and adequate kidney function. Women of childbearing age must test negative for pregnancy and agree to use contraception; men must also use contraception. Exclusions include active hepatitis C, uncontrolled autoimmune diseases, significant heart issues, certain dietary restrictions like grapefruit consumption, known bleeding disorders, uncontrolled infections, HIV positivity due to drug interactions risks.Check my eligibility
What is being tested?
The study tests the effectiveness of acalabrutinib and venetoclax in combination with or without early obinutuzumab in treating CLL/SLL. Acalabrutinib blocks enzymes needed by cancer cells to grow; venetoclax targets proteins essential for their growth; obinutuzumab is an immunotherapy that may help the immune system attack cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site from obinutuzumab; diarrhea and nausea from venetoclax; headaches and bruising from acalabrutinib. There's a risk of infection due to immune system impact by these drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after at least one treatment.
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I can take care of myself and am up and about more than half of the day.
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I am willing to change my acid reflux medication before starting treatment.
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My platelet count is above 30,000 and I haven't had a transfusion in the last 2 weeks.
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I have been diagnosed with CLL/SLL and need treatment according to 2018 guidelines.
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My kidney function, measured by creatinine clearance, is good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year end of cycle 14; each cycle 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year end of cycle 14; each cycle 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease assessment of BM undetectable-MRD4 (Relapsed/refractory [R/R] cohort)
Disease assessment of bone marrow (BM) undetectable-minimal residual disease,10-4 sensitivity (MRD4) (Treatment-naive [TN] cohort)
Secondary outcome measures
Incidence of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (acalabrutinib, venetoclax, early obinutuzumab)Experimental Treatment3 Interventions
Patients receive acalabrutinib PO BID on days 1-28 beginning cycle 2 and venetoclax PO BID on days 1-28 beginning cycle 3. Patients also receive obinutuzumab IV over 4-6 hours on days 1, 2, 8, and 15 of cycle 1 and day 1 of cycles 2-6. Patients who are BM MRD4-positive or in PR receive obinutuzumab IV over 4-6 hours on day 1 cycles 15-20. Treatment repeats every 28 days (or 42 days for cycle 14) for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (acalabrutinib, venetoclax, obinutuzumab)Active Control3 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Beginning cycle 3, patients receive venetoclax PO BID on days 1-28. Patients who are BM MRD4-positive or in PR also receive obinutuzumab IV over 4-6 hours on days 1, 2, 8, and 15 of cycle 15 and day 1 of cycles 16-20. Treatment repeats every 28 days (or 42 days for cycle 14) for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Acalabrutinib
2020
Completed Phase 2
~2050
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,153 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,905 Total Patients Enrolled
William G WierdaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune condition needing high-dose steroids.You have had serious allergic reactions to certain types of medications made from animals or you are known to be allergic to certain animal products.I do not have an active hepatitis B infection, or I am vaccinated against it.My white blood cell count is healthy, not due to cancer in my bone marrow.I haven't taken strong CYP3A affecting drugs in the last 7 days.I have been treated with both BTK and BCL2 inhibitors.My condition did not improve after at least one treatment.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I am over 65 or have a high-risk feature in my cancer.I can take care of myself and am up and about more than half of the day.I haven't had cancer, except for certain skin cancers or early-stage cervical or breast cancer, in the last 2 years.I am currently taking warfarin.I have not had a stroke or brain bleed in the last 6 months.I am HIV positive and on medication.You have a serious medical or mental health condition that could make participating in the study risky or affect the results.I am willing to change my acid reflux medication before starting treatment.I cannot take medications by mouth due to a digestive condition.I have active hepatitis C confirmed by a PCR test.I haven't had major treatments or live vaccines in the last 3 weeks, unless my disease is quickly getting worse.I am not pregnant, will use birth control during the study, and for some time after.My platelet count is above 30,000 and I haven't had a transfusion in the last 2 weeks.I have been diagnosed with CLL/SLL and need treatment according to 2018 guidelines.I do not have any ongoing serious infections.My kidney function, measured by creatinine clearance, is good.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (acalabrutinib, venetoclax, early obinutuzumab)
- Group 2: Arm I (acalabrutinib, venetoclax, obinutuzumab)
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 conditions is Obinutuzumab primarily utilized for?
"Obinutuzumab is a common recommendation for amino acid supplementation. It has also been found to be effective at treating acute coryza, mantle cell lymphoma after one prior therapy, and refractory follicular lymphoma."
Answered by AI
Has Obinutuzumab been greenlit by the FDA?
"The safety of Obinutuzumab was rated as a 2 on our scale, signifying that there is some clinical data demonstrating its security but no evidence to suggest it works."
Answered by AI
Is this medical experiment actively searching for participants?
"According to clinicaltrials.gov, this research is actively searching for participants. The trial was first published on July 29th 2020 and most recently updated August 17th 2022."
Answered by AI
How many individuals are participating in this experiment?
"Affirmative. According to clinicaltrials.gov, this trial is continuing to accept new participants since its posting date of July 29th 2020 and most recent update on August 17th 2022. 168 people are required at one particular medical site for the study to reach completion."
Answered by AI
Is this the inaugural trial of its kind?
"Currently, there are 371 live studies concerning Obinutuzumab spread out across 56 nations and 1772 cities. Baxter Healthcare Corporation's trail in 2007 was the first to explore its effects; it concluded Phase 4 drug approval with 4640 participants. In total, since then 161 trials have already reached completion."
Answered by AI
Have there been any previous investigations involving Obinutuzumab?
"As of now, 371 clinical trials are being conducted to assess the effectiveness of Obinutuzumab. 46 of these active studies have become Phase 3 trials and they span 17142 sites across Edmonton, Alberta."
Answered by AI
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