Your session is about to expire
← Back to Search
Protein Inhibitor
Acalabrutinib + Venetoclax/Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Adam S Kittai, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the first tumor assessment supports the response, at 1 and 3 years, or to the time of confirmed disease progression or death due to any cause
Awards & highlights
Study Summary
This trial is testing whether a combination of drugs shrinks tumors in patients with treatment-naive chronic lymphocytic leukemia.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia who haven't had previous cancer treatments, except for certain conditions like autoimmune diseases or symptom control. They must show specific symptoms or blood abnormalities as per iwCLL guidelines, have adequate organ function, and women of childbearing age must use effective contraception.Check my eligibility
What is being tested?
The trial is testing acalabrutinib combined with either venetoclax or obinutuzumab to see if they can shrink tumors in patients with untreated chronic lymphocytic leukemia. Patients will first receive acalabrutinib alone, then be randomly assigned to add one of the other drugs for further treatment cycles.See study design
What are the potential side effects?
Possible side effects include diarrhea, headache, increased risk of bleeding and infection due to low blood cell counts, irregular heart rhythm, muscle pain, and fatigue. Some may experience allergic reactions to the monoclonal antibody obinutuzumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL/SLL according to the 2018 guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 3 years up to time from start of combination therapy until next treatment is initiated
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 3 years up to time from start of combination therapy until next treatment is initiated
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of bone marrow undetectable minimal residual disease (uMRD), defined as tumor cell in 10,000 cells using standard flow based assay, achieved after completion of therapy
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall response rate (ORR)
+2 moreOther outcome measures
Discordant rate of uMRD between flow cytometry and NGS
Numbers of T, B, and NK cells during and after therapy
Presence or absence of genomic features
Side 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
2Treatment groups
Experimental Treatment
Group I: Arm II (acalabrutinib, venetoclax)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Patients also receive venetoclax PO QD on days 1-28 days of cycles 13-18. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (acalabrutinib, obinutuzumab)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 13 and day 1 of cycles 14-18. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tyrosine
FDA approved
Obinutuzumab
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,115 Total Patients Enrolled
Adam S Kittai, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have uncontrolled autoimmune blood disorders.I am on blood thinners like warfarin.My condition is considered high-risk.I cannot swallow pills or have serious stomach/intestine problems.I take more than 20 mg of prednisone daily for an autoimmune disease.I am 18 years old or older.I have a serious heart condition.I am not taking any drugs that strongly affect liver enzymes.I meet the treatment criteria for my CLL as per 2018 guidelines.My lymphoma or leukemia has spread to my brain or spinal cord.I do not have any other cancers that could shorten my life to under 2 years.I haven't had a stroke or major brain event in the last 6 months.I have been diagnosed with HIV.I have not received any live vaccines in the last 28 days.I am currently on IV antibiotics or antivirals for an infection.I have a bleeding disorder or am currently experiencing active bleeding.I need medication for stomach acid.I have been diagnosed with CLL/SLL according to the 2018 guidelines.I have not received any prior treatments for CLL, except for some exceptions.I have not had major surgery within the last 28 days.I have symptoms like weight loss, fatigue, fevers, or night sweats and my blood tests for liver and kidney function are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (acalabrutinib, venetoclax)
- Group 2: Arm I (acalabrutinib, obinutuzumab)
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.
How many participants are being recruited for this research trial?
"Affirmative. Clinicaltrials.gov has verified that this clinical trial is currently recruiting participants, having first been posted on September 13th 2022 and last updated November 2nd 2022. A total of 52 individuals are required for the single site study."
Answered by AI
What adverse effects may result from Acalabrutinib use?
"Acalabrutinib's safety is assessed as a 2 due to the fact that it has only undergone Phase 2 trials, meaning there is evidence of its security but no data on efficacy."
Answered by AI
Are there any openings for participants in this clinical experiment?
"According to the latest data hosted by clinicaltrials.gov, current recruitment for this medical trial is taking place since its initial posting on September 13th 2022 and as of November 2nd 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger