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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Rituximab and CAR T-Cell Therapy for Mantle Cell Lymphoma

Phase < 1
Recruiting
Led By Preetesh Jain, MD, PHD
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
Age ≥ 18 years
Cardiology clearance for receiving acalabrutinib and CART
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days after car t-cell infusion
Awards & highlights

Study Summary

This trial will test if a new combination of drugs can help control mantle cell lymphoma, a type of cancer.

Who is the study for?
This trial is for adults with newly diagnosed high-risk mantle cell lymphoma who haven't had treatment before. They must have specific genetic markers, be able to swallow pills, and have a good performance status (able to carry out daily activities). Women should not be pregnant and must use birth control. People can't join if they've had other cancers needing active treatment, certain heart or blood conditions, or are HIV positive.Check my eligibility
What is being tested?
The study tests a combination of acalabrutinib and rituximab followed by brexucabtagene autoleucel therapy in patients with untreated high-risk mantle cell lymphoma. The goal is to see if this regimen controls the disease better than current treatments.See study design
What are the potential side effects?
Possible side effects include nausea, diarrhea, headaches from acalabrutinib; infusion reactions like fever or chills from rituximab; and flu-like symptoms, low blood counts leading to infection risk or bleeding problems from brexucabtagene autoleucel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My heart has been cleared for specific cancer treatments.
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I can carry out all my usual activities without help.
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My lymphoma is confirmed with specific tests showing CD20 and certain genetic features.
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My MCL is considered high risk based on its specific features.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days after car t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days after car t-cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

Trial Design

2Treatment groups
Experimental Treatment
Group I: Brexucabtagene Autoleucel (Part 2)Experimental Treatment3 Interventions
Participants will have a procedure called leukapheresis to collect enough T cells.
Group II: Acalabrutinib and Rituximab (Part 1)Experimental Treatment4 Interventions
Participants may receive acalabrutinib and rituximab for up to 12 cycles. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2030
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

Acerta Pharma, LLCOTHER
6 Previous Clinical Trials
312 Total Patients Enrolled
Kite, A Gilead CompanyIndustry Sponsor
43 Previous Clinical Trials
3,631 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,345 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05495464 — Phase < 1
Mantle Cell Lymphoma Research Study Groups: Acalabrutinib and Rituximab (Part 1), Brexucabtagene Autoleucel (Part 2)
Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT05495464 — Phase < 1
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05495464 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available openings for this clinical trial?

"As per clinicaltrials.gov, this medical research is still looking for participants and has been since November 18th 2022 - the date it was first published online. The trial's information had most recently been updated on that same day."

Answered by AI

What is the current size of the sample population for this experiment?

"Affirmative. Clinicaltrials.gov shows that this research, which was initially posted on November 18th 2022, is actively searching for participants. The study requires 20 individuals from 1 centre to take part in the clinical trial."

Answered by AI
~13 spots leftby Mar 2027