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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Rituximab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Paul Barr
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat CLL/SLL. The combo is designed to be safer and more effective than current treatments.
Who is the study for?
This trial is for adults with untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have symptoms like night sweats, weight loss, or fatigue. They must be able to take oral meds and not have had previous CLL/SLL treatment. Participants need proper liver and kidney function and can't be on certain medications or have uncontrolled heart issues.Check my eligibility
What is being tested?
The study tests a combination of acalabrutinib (a pill) and rituximab (an injection under the skin), given frequently in low doses, to see if they're safe and effective against CLL/SLL when used together for the first time in patients.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from rituximab, increased risk of infections, bleeding problems, heart rhythm issues due to acalabrutinib, as well as general side effects like headaches, diarrhea, muscle pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with a complete response rate (CR) at 1 year of therapy
Secondary outcome measures
Proportion of subjects with minimal residual disease in peripheral blood and bone
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
1Treatment groups
Experimental Treatment
Group I: Acalabrutinib and Rituximab treatmentExperimental Treatment2 Interventions
Rituximab: administered 2 times weekly for 6 cycles. Initial dose day 1: 50 mg IV, Then 50 mg SQ thereafter.
Acalabrutinib: 100 mg po BID starting on day 8 of cycle 1.
Patients who have attained a complete response who are also MRD negative at cycle 12 will undergo a BM biopsy to confirm CR and MRD negatively. If confirmed, the patient will stop therapy and be followed until disease progression.
Patients not in a MRD negative CR, will continue acalabrutinib.
Repeat response assessments (CTs, MRD testing in blood) will be performed at 24 cycles of therapy for those continuing on acalabrutinib. If both negative the patient will undergo a BM biopsy to confirm CR and MRD negativity. If confirmed, the patient will stop therapy and be followed until disease progression. In the absence of a CR or if MRD +, acalabrutinib may be continued until disease progression, unacceptable toxicity or physician/patient discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
836 Previous Clinical Trials
518,054 Total Patients Enrolled
17 Trials studying Lymphoma
20,570 Patients Enrolled for Lymphoma
Paul BarrPrincipal Investigator - University of Rochester
Strong Memorial Hospital
Northeastern Ohio Universities College Of Medicine (Medical School)
University Hosp Of Cleveland (Residency)
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Lymphoma
42 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that causes frequent or severe bleeding.You have been experiencing very heavy night sweats for more than a month.You are able to swallow pills and keep them down in your stomach.You have a condition called autoimmune hemolytic anemia or immune thrombocytopenic purpura (ITP) that is not well controlled.You are taking blood thinners like warfarin or other similar medications within a week of starting the study drug.You have symptoms like fatigue, weight loss, or pain that are not caused by an infection.Your overall physical condition is good, with a performance status score of 2 or less, unless it is specifically related to chronic lymphocytic leukemia (CLL).You have chest pain (angina) that doesn't get better with medication.Your spleen is swollen and causing significant symptoms or is growing rapidly in size.You have very large, growing, or causing symptoms, swollen lymph nodes.You have a type of anemia or low platelet count caused by an autoimmune condition that doesn't improve with common treatments like corticosteroids.You have lost a lot of weight (more than 10% of your body weight) without trying in the past 6 months.You experience extreme tiredness that affects your daily activities.You have experienced a severe allergic reaction called anaphylaxis in the past when receiving certain medications for your condition.You have been diagnosed with or are suspected to have a condition called progressive multifocal leukoencephalopathy (PML).You have experienced bleeding in the brain or a stroke within the past 6 months.You have a condition in your stomach or intestines that makes it hard for your body to absorb medicine taken by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib and Rituximab treatment
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.
For what indications is Acalabrutinib typically prescribed?
"Acalabrutinib is regularly employed to manage diffuse large b-cell lymphoma (DLBCL). Additionally, this prescription can be used in association with numerous other clinical conditions such as B-Cell Lymphomas, Polyangium, and Pemphigus Vulgaris."
Answered by AI
Is Acalabrutinib hazardous to patients' health?
"Acalabrutinib has been assessed to have a safety rating of 2. This is due to its Phase 2 trial status, which suggests that while there are some data points affirming the drug's security, none exist as evidence for efficacy."
Answered by AI
Is there a possibility of enrolling in this experiment as an experimental subject?
"Clinicaltrials.gov reveals that this clinical trial, which first appeared on March 25th 2019 and was last edited on February 7th 2022, is not currently recruiting participants. Nevertheless, 3319 other trials are still accepting patients at the moment."
Answered by AI
What is the maximum capacity of participants in this medical experiment?
"This clinical experiment is no longer enrolling participants. It was initially published on March 25th 2019 and its last update occurred on February 7th 2022. If you are seeking other research opportunities, 2862 studies for leukemia, lymphocytic, chronic B-cell have openings as well as 457 trials that involve the medication Acalabrutinib."
Answered by AI
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