A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

NCT ID: NCT02735876

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31

Brief Summary

This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

acalabrutinib plus rituximab

Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

rituximab

Intervention Type: DRUG

ibrutinib

Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).

Group Type: ACTIVE_COMPARATOR

ibrutinib

Intervention Type: DRUG

acalabrutinib

Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

Interventions

acalabrutinib

Intervention Type: DRUG

ibrutinib

Intervention Type: DRUG

rituximab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years of age.
• Pathologically confirmed mantle cell lymphoma (MCL).
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest).
• Disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (MCL).
• Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria

• Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
• Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor.
• Significant cardiovascular disease.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
• Uncontrolled active systemic fungal, bacterial, viral, or other infection.
• Known history of infection with human immunodeficiency virus (HIV).
• History of hepatitis B (HBV) infection or active infection with hepatitis C (HCV).
• Breastfeeding or pregnant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acerta Pharma BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandeep Inamdar, MBBS

Role: STUDY_DIRECTOR

Acerta Pharma, LLC

Other Identifiers

ACE-LY-309

Identifier Type: -

Identifier Source: org_study_id