Acalabrutinib + BR/VR for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects with Mantle Cell Lymphoma

Eligibility Criteria

This trial is for adults diagnosed with Mantle Cell Lymphoma (MCL) who have not been treated before. Participants must be in relatively good health, with an ECOG performance status of ≤ 2, and agree to use effective contraception. Pregnant or breastfeeding individuals, those with significant heart disease or gastrointestinal issues that affect drug absorption, or active infections are excluded.

Inclusion Criteria

I have mantle cell lymphoma and haven't received any treatment yet.

I can take care of myself but might not be able to do heavy physical work.

My diagnosis is Mantle Cell Lymphoma.

Exclusion Criteria

I do not have any major issues with my stomach or intestines that affect how I absorb food or medicine.

I do not have an ongoing infection that is not improving with treatment.

Participant Groups

The study is testing Acalabrutinib combined with either Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR). It's a Phase 1b trial where all participants receive the experimental treatment combinations to determine safety and dosage levels.

3Treatment groups

Experimental Treatment

Group I: Part 2: Acalabrutinib+VR in TN patientsExperimental Treatment1 Intervention

Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients

Group II: Part 1: Acalabrutinib+BR in TN patientsExperimental Treatment1 Intervention

Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients

Group III: Part 1: Acalabrutinib+BR in RR patientsExperimental Treatment1 Intervention

Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: