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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib +/- Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Sameer A. Parikh, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Diagnosis of biopsy-proven small lymphocytic lymphoma (SLL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is studying how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
Who is the study for?
Adults diagnosed with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma, who have not been treated before, can join this trial. They must be in good health overall and able to provide blood and saliva samples for research. Pregnant or nursing individuals, those with certain heart conditions, active infections like hepatitis B/C or HIV on treatment are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of acalabrutinib alone versus combined with obinutuzumab in treating patients. Acalabrutinib blocks enzymes that cancer cells need to grow while obinutuzumab may help the immune system attack cancer.See study design
What are the potential side effects?
Acalabrutinib might cause headaches, diarrhea, muscle pain, and increased risk of bleeding. Obinutuzumab can lead to infusion reactions (like fever), low blood cell counts increasing infection risk, and potential liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I have been diagnosed with small lymphocytic lymphoma.
Select...
I have not received any treatment for my condition.
Select...
My tests show I do not have mantle cell lymphoma.
Select...
I have been diagnosed with chronic lymphocytic leukemia.
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I am 18 years old or older.
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
Rate of minimal residual disease (MRD)-negative complete response (Arm A and Arm B)
Time to first therapy in patients (Arm C)
Secondary outcome measures
Incidence of adverse events rates (Arms A and B)
Overall response rate (Arms A and B)
Overall survival (Arm C)
+4 moreOther outcome measures
Bone marrow hematopoiesis (Arms A and B)
Percent killing of chronic lymphocytic leukemia (CLL) B-cells (Arms A and B)
Quality of life measures
+2 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (acalabrutinib, obinutuzumab)Experimental Treatment4 Interventions
Patients receive acalabrutinib PO BID on days 1-28 and obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1 and days 1 of subsequent cycles. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive acalabrutinib PO BID on days 1-84. Treatment repeats every 84 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment with acalabrutinib If MRD negative CR/CRi is not achieved after 12 cycles.
Group II: Arm A (acalabrutinib)Experimental Treatment3 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive acalabrutinib PO BID on days 1-84. Treatment repeats every 84 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment with acalabrutinib If MRD negative CR/CRi is not achieved after 12 cycles.
Group III: Arm C (observation)Active Control3 Interventions
Patients will be observed every 6 months for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Obinutuzumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,013 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,211 Patients Enrolled for Lymphoma
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,853 Total Patients Enrolled
62 Trials studying Lymphoma
27,823 Patients Enrolled for Lymphoma
Sameer A. Parikh, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I have been diagnosed with small lymphocytic lymphoma.I was diagnosed with CLL/SLL more than 2 years ago.I am nursing and have high or very high risk CLL-IPI.I have not received any treatment for my condition.I agree to give a bone marrow sample for research.My blood clotting tests are normal or managed if I'm on blood thinners.I am not on any experimental drugs for my cancer.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.I have previously been treated with specific cancer drugs like ibrutinib or venetoclax.I am recommended to undergo chemotherapy.I have not had a stroke or brain bleed in the last 6 months.My tests show I do not have mantle cell lymphoma.I have not had any other cancer within the last 2 years.My hemoglobin level is at least 11.0 g/dL.I am HIV positive and currently on antiretroviral therapy.I need treatment with a strong medication that affects liver enzymes.I have symptoms related to my disease.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have been diagnosed with chronic lymphocytic leukemia.I have a bleeding disorder like hemophilia.I have been diagnosed with progressive multifocal leukoencephalopathy.I have been diagnosed with lymphoma or leukemia in my brain.I am taking warfarin or similar blood thinners and will continue during the study.I am 18 years old or older.I have not received a live vaccine in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (acalabrutinib, obinutuzumab)
- Group 2: Arm A (acalabrutinib)
- Group 3: Arm C (observation)
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.
Are there any remaining opportunities to join this research initiative?
"The details hosted on clinicaltrials.gov confirm that this medical trial is open to participants, with the initial post date being September 10th 2018 and last updated 8th of September 2022."
Answered by AI
Has Acalabrutinib obtained clearance from the Food and Drug Administration?
"With data pointing to its safety, but not yet efficacy, Acalabrutinib was given a score of 2."
Answered by AI
To what maladies does Acalabrutinib commonly provide relief?
"Acalabrutinib is a viable solution for managing refractory follicular lymphoma, as well as renal dysfunction, chronic lymphocytic leukemia, and kidney failure."
Answered by AI
What are the ultimate objectives of this clinical research endeavor?
"The main goal of this clinical trial, evaluated after 12 courses and starting from the date of enrolment, is to determine whether patients experience a Rate of minimal residual disease (MRD)-negative complete response. Additionally, Secondary objectives include Time to next therapy which will be estimated via Kaplan-Meier methodology for comparison between both arms with log-rank statistics., Overall response rate calculated by dividing those who achieved CR, CRi, CCR, nPR or PR during treatment among all evaluable patients in each arm., and Progression-free survival that also uses the method of Kaplan-Meier for comparison between both arms through log rank statistic"
Answered by AI
Is this research experiment a groundbreaking endeavor?
"Acalabrutinib has been a focus of clinical research for over 13 years, starting with the Baxter Healthcare Corporation-sponsored study in 2007. After garnering positive results from 4640 participants, the drug was granted Phase 4 approval and is now being tested in active trials across 1433 cities and 55 countries."
Answered by AI
Are there any other scholarly works that have discussed the effectiveness of Acalabrutinib?
"Acalabrutinib was initially researched in 2007 at Regional Hospital Jessa's Surgical Intensive Care Unit. Currently, there are a total of 763 completed trials with 195 recruiting participants--many located around Scottsdale, Arizona."
Answered by AI
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