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Bruton's Tyrosine Kinase (BTK) Inhibitor
Venetoclax + Obinutuzumab +/- Acalabrutinib for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Jacob D Soumerai, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age over 18 years
Diagnosis of CLL or SLL according to WHO criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they are effective in treating CLL or SLL. The drugs involved are obinutuzumab, venetoclax, and acalabrutinib.
Who is the study for?
Adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment and have previously received systemic therapy. They must be in good enough health, not pregnant, agree to contraception, and not have certain heart conditions or other serious illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing a combination of drugs: obinutuzumab, venetoclax, and possibly acalabrutinib. It aims to find out if these drugs can effectively treat CLL/SLL when given together compared to current standard treatments.See study design
What are the potential side effects?
Possible side effects include infections due to a weakened immune system, allergic reactions to the medication components, liver problems, digestive issues like nausea or diarrhea, fatigue, and an increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I have been diagnosed with CLL or SLL.
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My kidney function, measured by creatinine or its clearance, is within the normal range.
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I have received treatment for chronic lymphocytic leukemia.
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I can care for myself but may not be able to do active work.
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My CLL is classified as high or intermediate risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants alive at 1 year
Secondary outcome measures
Complete response rate
Frequency of undetectable minimum residual disease (uMRD) after 12 Months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0.
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Venetoclax-Obinutuzumab +/- AcalabrutinibExperimental Treatment3 Interventions
A treatment cycle is defined as 28 consecutive days. Participants with undetectable MRD (uMRD) at 1 year will complete an additional 1 year of VO then stop therapy.
Participants with high detectable MRD at 1 year will complete an additional 1 year of VO plus acalabrutinib then stop therapy.
Participants with low detectable MRD at 1 year will complete an additional 1 year of VO alone. If this eradicates MRD, they will stop therapy. If there is still residual MRD, they will complete an additional 1 year of IVO then stop therapy.
If progression occurs on VO, I will be added and IV will be administered indefinitely. After 2 years, V may be stopped and I continued as monotherapy at investigator discretion.
Infused Study Drug: Obinutuzumab on Days 1, 2, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 1-6
Oral Study Drugs: Venetoclax daily starting on Cycle 1 Day 22
Oral Drug: acalabrutinib daily for Days 1-28 (if applicable)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Obinutuzumab
FDA approved
Acalabrutinib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,441 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,103 Total Patients Enrolled
Jacob D Soumerai, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My CLL has transformed into an aggressive form of lymphoma.I am over 18 years old.I have been diagnosed with CLL or SLL.I have not had a brain hemorrhage or stroke in the last 6 months.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.I need medication to prevent blood clots.My kidney function, measured by creatinine or its clearance, is within the normal range.My bone marrow functions well, not affected by my current illness.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had treatment for another cancer in the last 3 years, except for low-risk prostate cancer or local treatments.I have had progressive multifocal leukoencephalopathy in the past.I haven't taken strong medication affecting liver enzymes in the last week.I have had hepatitis B but don't currently, and I'm willing to take preventive treatment and monthly tests.I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.I understand and commit to reliable contraception methods during the trial.I've had treatment with specific cancer drugs but still show no minimal signs of my disease.I have received treatment for chronic lymphocytic leukemia.My organs are functioning well.I have a history of HIV or active hepatitis B or C.I have a significant history of liver problems.I can care for myself but may not be able to do active work.I haven't had major surgery in the last 4 weeks and don't expect to need one soon.I tested positive for hepatitis C but do not currently have the virus in my blood.I have severe heart failure.I have a condition that affects how my body absorbs medication taken by mouth.You are allergic to obinutuzumab or any of its ingredients.I need treatment as per the latest CLL guidelines.You have eaten grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days before taking the study medication.My CLL is classified as high or intermediate risk.You have a mental health condition or personal circumstances that might make it difficult for you to follow the study rules.I have a bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax-Obinutuzumab +/- Acalabrutinib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Is this a pioneering clinical trial?
"Since 2014, Acerta Pharma BV has sponsored research for Obinutuzumab. Initially studied with 306 participants in its Phase 1 & 2 trials, today it is being researched across 55 countries and 1407 cities with 339 active studies."
Answered by AI
Does the FDA recognize Obinutuzumab as a legitimate pharmaceutical?
"Our team of experts at Power have assigned Obinutuzumab a safety score of 2, as it is in the Phase 2 trial stage. At this point, there is some preliminary evidence for its safety but none that suggests efficacy."
Answered by AI
Does this research initiative have any open slots for participation?
"According to information on clinicaltrials.gov this trial is currently recruiting patients, having been initially posted on October 19th 2020 and edited most recently on August 9th 2021."
Answered by AI
Could you direct me to any other research related to Obinutuzumab?
"Presently, 339 medical studies are investigating the efficacy of Obinutuzumab with 43 trials in their late-stage. Toronto is a principal centre for these investigations yet there are 10710 other sites worldwide conducting clinical research related to Obinutuzumab."
Answered by AI
What medical condition is Obinutuzumab typically prescribed for?
"Obinutuzumab is considered a viable option for managing small lymphocytic lymphoma, lymphoid leukemia, and mantle cell lymphoma that have not responded to prior therapies."
Answered by AI
How many participants are taking part in this medical trial?
"Yes, according to clinicaltrials.gov's records this medical trial is still open for enrollment and was first announced on October 19th 2020 with the latest update occurring August 9th 2021. Right now, 40 patients are needed across 3 sites."
Answered by AI
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