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

Mantle Cell Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02735876
• Other study ID #: ACE-LY-309
• Status: Withdrawn
• Phase: Phase 3
• First received: April 8, 2016
• Last updated: May 12, 2016
• Start date: May 2016

Study information

• Verified date: April 2016
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• acalabrutinib

• ibrutinib

• rituximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acerta Pharma BV

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation.		48 months	Yes
Primary	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	No
Secondary	Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).		48 months	No
Secondary	Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).		48 months	No
Secondary	Overall survival (OS).		48 months	No
Secondary	IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).		48 months	No