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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Rituximab for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Luhua (Michael) Wang
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
Serum bilirubin <1.5 mg/dl and creatinine clearance minimum to 50 mL/min per the Cockcroft- Gault formula
Newly diagnosed elderly MCL (age ≥65 years) with no prior therapy under all risk categories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Study Summary
This trialstudies acalabrutinib & rituximab to treat mantle cell lymphoma in elderly patients. Acalabrutinib may stop cancer growth & rituximab may kill cancer cells.
Who is the study for?
This trial is for people aged 65 or older with newly diagnosed mantle cell lymphoma, which has specific biological markers. They must be able to swallow pills, have no major health issues that could interfere with the study, and not be on certain medications. Participants need normal organ function and controlled cardiovascular conditions. Pregnant women or those unable to use effective birth control are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of acalabrutinib (a drug that blocks enzymes needed for cancer cell growth) and rituximab (an antibody targeting B-cells). It aims to see how well this combo works in treating elderly patients who haven't had any previous treatments for their mantle cell lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as infusion reactions from rituximab, bleeding risks due to acalabrutinib's effect on blood clotting, heart rhythm changes, infections due to lowered immunity, liver problems, fatigue, nausea and other gastrointestinal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney and liver functions are within the required range.
Select...
I am 65 or older with newly diagnosed mantle cell lymphoma and have not received any treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission rate
Incidence of adverse events (AEs)
Secondary outcome measures
Overall response rate
Overall survival (OS)
Progression free survival (PFS)
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: Treatment (acalabrutinib, rituximab)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV over 3-4 hours on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2-12, 14, 18, 20, 22, and 24. Cycles repeats every 28 days for up to 24 months or until complete remission is achieved 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
Rituximab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,163 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
577 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke in the last 6 months.I haven't had any recent bleeding disorders or strokes.I am willing to follow strict birth control measures during and after treatment.I have a tumor that is larger than 1.5 cm, confirmed by a PET-CT scan.I have had cancer before, but it was either skin cancer treated successfully, cervical or prostate cancer in situ treated successfully, or any other cancer I've been free of for 3+ years.I do not have significant heart issues or uncontrolled serious conditions.My physical health has been stable for the last 2 weeks.I am cancer-free except for minor skin cancers or cancers in remission with a life expectancy over 3 years.I have been taking more than 20 mg of steroids daily for over 2 weeks.I can take pills without any trouble and can follow the study's requirements.I need to take warfarin or a similar drug for blood thinning.I have severe stomach or bowel problems that affect my ability to absorb medications.My kidney and liver functions are within the required range.You have had a severe allergic reaction or anaphylaxis to the study drug or any of its ingredients.My white blood cell and platelet counts are within the required range.I have uncontrolled AIHA or ITP.I do not have any ongoing serious infections.I do not have brain involvement with my lymphoma or a condition called PML.My lymphoma is confirmed to be mantle cell type with specific genetic markers.I have previously been treated with acalabrutinib or for mantle cell lymphoma.I am 65 or older with newly diagnosed mantle cell lymphoma and have not received any treatment.I have not received a live vaccine within 4 weeks before or during my treatment with Rituximab.I need medication that strongly affects liver enzymes.I have or had progressive brain infection (PML).I haven't had major surgery in the last 30 days or have fully recovered if I did.My heart condition is stable, and I have a doctor's approval to join the trial.My liver function tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, rituximab)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 there currently capacity for new participants in this clinical experiment?
"Clinicaltrials.gov confirms that this research has resumed recruitment; the original post was published on June 30th 2021 and it received its last update on November 14th 2022."
Answered by AI
What drawbacks have been recorded in regards to Acalabrutinib usage?
"Although acalabrutinib is yet to display its efficacy in a clinical setting, there is evidence of safety from phase 2 trials that warrants assigning it a score of two."
Answered by AI
How many individuals are being offered the opportunity to partake in this scientific examination?
"Affirmative. According to clinicaltrials.gov, this investigation is open for recruitment and has been since June 30th 2021 after its most recent update on November 14th 2022. The trial requires 50 participants across 1 site."
Answered by AI
What diseases does Acalabrutinib typically treat?
"Physicians commonly use acalabrutinib to facilitate healing procedures. It also has been known to prove effective in treating acute kidney failure, diffuse large b-cell lymphoma (dlbcl), and other varieties of B-cell lymphomas."
Answered by AI
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