Acalabrutinib + Combination Therapy for B-Cell Lymphoma

Palo Alto (17 mi)

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

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

My cancer is a type of marginal zone lymphoma.

I have MALT lymphoma and am not infected with Helicobacter pylori.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I do not have significant issues with my digestive system.

I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

Treatment Details

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).

5Treatment groups

Experimental Treatment

Group I: Part 3: acalabrutinib Regimen 1Experimental Treatment3 Interventions

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

Group II: Part 2: acalabrutinib Regimen 2Experimental Treatment2 Interventions

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

Group III: Part 2: acalabrutinib Regimen 1Experimental Treatment1 Intervention

acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects

Group IV: Part 1: acalabrutinib Regimen 2Experimental Treatment2 Interventions

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

Group V: Part 1: acalabrutinib Regimen 1Experimental Treatment1 Intervention

acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects