Study on Acalabrutinib Maintenance for Treating Large B-cell Lymphoma
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT05256641
This clinical trial is exploring the use of acalabrutinib, a medication that may help prevent cancer from returning, in patients with large B-cell lymphoma who are at high risk of relapse after cellular therapy.
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Program Overview
This study is investigating the safety and effectiveness of using acalabrutinib as a maintenance treatment for patients with large B-cell lymphoma who have a high risk of their cancer coming back after receiving cellular therapy. Acalabrutinib is a drug that may help stop cancer cells from growing and spreading.
Description
The main goal of this study is to determine if acalabrutinib is safe and well-tolerated when used as a maintenance treatment after cellular therapy in patients with large B-cell lymphoma who are at high risk of relapse. Researchers also want to see how effective acalabrutinib is in keeping the cancer in remission and improving survival rates. They will also look at how well patients respond to the treatment and if there are any side effects that require dose adjustments or stopping the medication.
Participants will be divided into three groups based on their previous treatments:
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Group I (Allogeneic Hematopoietic Cell Transplantation Group): Starting on day 90, patients will take acalabrutinib once daily, then twice daily if no longer on certain antifungal medications, until day 365 unless the cancer progresses or side effects become unacceptable.
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Group II (Autologous Stem Cell Transplantation Group): Starting on day 60, patients will take acalabrutinib once daily, then twice daily from day 74 if no dose reductions are needed, until day 365 unless the cancer progresses or side effects become unacceptable.
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Group III (CAR-T Cell Therapy Group): Starting anytime between days 28-104, patients will take acalabrutinib twice daily until day 365 unless the cancer progresses or side effects become unacceptable.
After completing the study treatment, patients will have a follow-up visit 30 days later.
Eligibility Criteria
Inclusion Criteria
- Ages 18-70 years
- Undergoing autologous stem cell transplantation (ASCT) or FDA-approved CAR T-cell therapy for:
- High grade B-cell lymphoma with specific genetic changes
- Large B-cell lymphoma with a history of CNS involvement
- Transformation of indolent lymphoma to large B-cell lymphoma
- High risk international prognostic index (IPI) score 4 or 5
- Undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma
- ECOG performance status 0-2
- For post-ASCT and post-alloHCT participants:
- Partial or complete response before transplantation
- Reduced-intensity conditioning regimen
- Enrollment by day 90
- For post-CAR T-cell therapy participants:
- Partial or complete response after therapy
- Enrollment by day 104
- Ability to give informed consent
- Women of childbearing potential must use effective contraception during the study and for 2 days after the last dose
- Willing to participate in all study procedures
- Adequate blood counts and organ function
Exclusion Criteria
- Cord blood as donor source in alloHCT
- Severe heart conditions
- Poor kidney function
- Long-term use of certain medications that cannot be replaced
- Severe graft-versus-host disease
- Recent blood transfusions
- Active infections
- History of certain brain infections
- Recent use of investigational drugs
- Recent major surgery
- Digestive issues affecting medication absorption
- Recent live virus vaccination
- HIV infection
- Bleeding disorders
- Use of certain blood thinners
- Use of certain medications affecting drug metabolism
- Pregnant or breastfeeding
- Participation in another clinical trial
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