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

A Randomized, Multicenter, Open Label, Phase 3 Study of Acalabrutinib (ACP-196) in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib Alone in Subjects With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02735876

Enrollment

Registered

2016-04-13

Start date

2016-05-31

Completion date

Unknown

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Keywords

Bruton tyrosine kinase inhibitor, Btk, ACP-196, Mantle Cell Lymphoma, MCL

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).

Interventions

DRUGacalabrutinib

DRUGibrutinib

DRUGrituximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2.	48 months

Secondary

Measure	Time frame
Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).	48 months
Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).	48 months
Overall survival (OS).	48 months
IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).	48 months

Other

Measure	Time frame
Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation.	48 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026