Clinical trial NCT02735876: A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
Keywords: Bruton tyrosine kinase inhibitor
Btk
ACP-196
Mantle Cell Lymphoma
MCL
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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.
timeFrame: 48 months
Secondary outcomes:
measure: Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
timeFrame: 48 months
measure: Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
timeFrame: 48 months
measure: Overall survival (OS).
timeFrame: 48 months
measure: IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
timeFrame: 48 months
Other outcomes:
measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation.
timeFrame: 48 months
Locations:
Study officials:
affiliation: Acerta Pharma, LLC
name: Sandeep Inamdar, MBBS
role: STUDY_DIRECTOR
References: