Acalabrutinib + Combination Therapy for B-Cell Lymphoma

Recruiting at40 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Research Team

Acerta Call center

Principal Investigator

Acerta Pharma, LLC

Eligibility Criteria

Adults over 18 with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments. Participants must not be pregnant, should agree to use contraception if they can have children, and cannot have serious heart issues or gastrointestinal conditions that could affect the study.

Inclusion Criteria

Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children

I have splenic marginal zone lymphoma with an additional measurable lesion.

I have Follicular Lymphoma that needs treatment and has either come back or didn't respond to previous treatments.

Exclusion Criteria

I do not have significant issues with my digestive system.

I do not have a severe illness that could risk my safety in the study.

Breastfeeding or pregnant

Treatment Details

Interventions

• Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• Lenalidomide (Immunomodulatory Agent)
• Rituximab (Monoclonal Antibodies)

Trial Overview The trial is testing Acalabrutinib alone or combined with Rituximab for relapsed/refractory Follicular Lymphoma (FL), and its combination with Rituximab and Lenalidomide for the same condition. It aims to assess safety and effectiveness, including overall response rate in Marginal Zone Lymphoma (MZL).

Participant Groups

Group I: Part 3: acalabrutinib Regimen 1 Experimental Treatment 3 Interventions

acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects

Group II: Part 2: acalabrutinib Regimen 2 Experimental Treatment 2 Interventions

acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects

Group III: Part 2: acalabrutinib Regimen 1 Experimental Treatment 1 Intervention

acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects

Group IV: Part 1: acalabrutinib Regimen 2 Experimental Treatment 2 Interventions

acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects

Group V: Part 1: acalabrutinib Regimen 1 Experimental Treatment 1 Intervention

acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+

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