24 Participants Needed

Acalabrutinib Maintenance for Large B-cell Lymphoma

Recruiting at 2 trial locations
VK
Overseen ByVlad Kustanovitch
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use strong CYP3A inhibitors or inducers, and you must not be on long-term posaconazole or similar medications. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Acalabrutinib for treating large B-cell lymphoma?

Acalabrutinib has been shown to be effective in treating chronic lymphocytic leukemia (CLL) by significantly extending the time patients live without their disease getting worse compared to standard treatments. It works by targeting a specific protein that helps cancer cells grow, and it has been approved for use in CLL, suggesting potential benefits for other similar types of blood cancers.12345

How does the drug acalabrutinib differ from other treatments for large B-cell lymphoma?

Acalabrutinib is a second-generation drug that specifically targets and inhibits Bruton tyrosine kinase (BTK), making it more selective and potent compared to older treatments like ibrutinib. This increased selectivity may lead to fewer side effects and better adherence to treatment.24567

What is the purpose of this trial?

This phase Ib/II trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.

Research Team

Caspian Oliai, MD, MS - Hematologic ...

Caspian Oliai

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 18-70 with large B-cell lymphoma who've had a positive response to CAR T-cell therapy or stem cell transplant. They must have good kidney function, not be pregnant, and agree to use contraception. Exclusions include heart problems, recent transfusions, active infections, certain drug treatments, and inability to swallow pills.

Inclusion Criteria

- Hemoglobin > 8 g/dL independent of transfusions
My PET-CT scan shows partial or complete response 1-3 months after CAR T-cell therapy.
- Absolute neutrophil count (ANC) > 500/uL (microliters)
See 20 more

Exclusion Criteria

I received a platelet transfusion in the last week.
My kidney function is severely reduced.
I have not received a live virus vaccine in the last 28 days.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acalabrutinib maintenance following cellular therapy, starting between days 28-104 and continuing until day 365

Approximately 9-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 5 years

Treatment Details

Interventions

  • Acalabrutinib
Trial Overview The trial tests acalabrutinib as a maintenance treatment after cellular therapy in patients at high risk of relapse. Acalabrutinib is designed to block cancer growth by inhibiting specific proteins within the cancer cells.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Group III (acalabrutinib)Experimental Treatment1 Intervention
Beginning anytime between days 28-104, patients receive acalabrutinib PO BID until day 365 in the absence of disease progression or unacceptable toxicity.
Group II: Group II (acalabrutinib)Experimental Treatment1 Intervention
Beginning day 60, patients receive acalabrutinib PO QD and then PO BID from day 74 if there are no dose reductions until day 365 in the absence of disease progression or unacceptable toxicity.
Group III: Group I (acalabrutinib)Experimental Treatment1 Intervention
Beginning day 90, patients receive acalabrutinib PO QD and then PO BID once no longer on prophylactic antifungal (CYP34A inhibitors) until day 365 in the absence of disease progression or unacceptable toxicity.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

Acalabrutinib, a selective Bruton tyrosine kinase inhibitor, showed improved safety outcomes compared to other targeted therapies for treatment-naïve chronic lymphocytic leukemia (CLL) patients, although it was associated with a higher risk of neutropenia and leukopenia in some cases.
The analysis indicated that acalabrutinib (with or without obinutuzumab) had similar efficacy in terms of progression-free survival compared to other treatments, suggesting it is a safe and effective option for CLL patients.
Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia.Davids, MS., Telford, C., Abhyankar, S., et al.[2021]
In a phase 3 study involving 535 patients with treatment-naive chronic lymphocytic leukaemia, acalabrutinib combined with obinutuzumab or as a monotherapy significantly improved progression-free survival compared to the standard treatment of obinutuzumab with chlorambucil, with median survival not reached for the acalabrutinib groups versus 22.6 months for the chlorambucil group.
The safety profile of acalabrutinib was favorable, with fewer infusion reactions and a lower incidence of grade 3 or higher adverse events compared to the obinutuzumab-chlorambucil group, indicating it is a viable chemotherapy-free treatment option for patients.
Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial.Sharman, JP., Egyed, M., Jurczak, W., et al.[2021]
Acalabrutinib has been approved in the EU for treating both treatment-naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), showing significant improvements in progression-free survival compared to standard therapies in two phase III trials involving adult patients.
The safety profile of acalabrutinib is generally acceptable, with common side effects including headache, diarrhea, and infections, and the overall benefit-risk ratio is considered positive for its use in CLL.
EMA Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia.Delgado, J., Josephson, F., Camarero, J., et al.[2021]

References

Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. [2021]
Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. [2021]
EMA Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia. [2021]
ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. [2021]
Acalabrutinib: Managing Adverse Events and Improving Adherence in Patients With Mantle Cell Lymphoma. [2022]
Preclinical Evaluation of the Novel BTK Inhibitor Acalabrutinib in Canine Models of B-Cell Non-Hodgkin Lymphoma. [2018]
Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. [2018]
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