NCT04404088

Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

A Phase II Study of Acalabrutinib, Lenalidomide, and Rituximab (aR2) in Patients With Previously Untreated Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well acalabrutinib, lenalidomide, and rituximab work in treating patients with CD20 positive stage III-IV, grade 1-3a follicular lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib, lenalidomide, and rituximab may help to control the disease.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of acalabrutinib combined with rituximab and lenalidomide in patients with previously untreated follicular lymphoma (FL) (determined by complete remission \[CR\] rate by the end of treatment). SECONDARY OBJECTIVES: I. To evaluate the efficacy of acalabrutinib combined with rituximab and lenalidomide in subjects with FL as assessed by objective response rate (ORR) at the end of treatment, duration of response (DOR), progression rate within 24 months from treatment initiation (progression-free survival \[PFS\] 24), PFS and overall survival (OS). II. To evaluate the safety and tolerability of acalabrutinib combined with rituximab and lenalidomide in previously untreated subjects with FL. EXPLORATORY OBJECTIVE: I. To determine the pharmacodynamic effects and investigate biomarkers of response and resistance of the 3-drug combination. OUTLINE: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Beginning cycle 2, patients receive lenalidomide PO once daily (QD) on days 1-21 and rituximab intravenously (IV) on days 1, 8, 15, and 22 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Conditions

• Ann Arbor Stage III Grade 1 Follicular Lymphoma
• Ann Arbor Stage III Grade 2 Follicular Lymphoma
• Ann Arbor Stage III Grade 3 Follicular Lymphoma
• Ann Arbor Stage IV Grade 1 Follicular Lymphoma
• Ann Arbor Stage IV Grade 2 Follicular Lymphoma
• Ann Arbor Stage IV Grade 3 Follicular Lymphoma
• Grade 3a Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Given PO
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2020-07-16
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2020-05-27
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study