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

Primary Purpose

Mantle Cell Lymphoma

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

acalabrutinib

ibrutinib

rituximab

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Bruton tyrosine kinase inhibitor, Btk, ACP-196, Mantle Cell Lymphoma, MCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

acalabrutinib plus rituximab

ibrutinib

acalabrutinib

Arm Description

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).

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Overall survival (OS).

IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Full Information

NCT ID

NCT02735876

First Posted

April 8, 2016

Last Updated

May 12, 2016

Sponsor

Acerta Pharma BV

1. Study Identification

Unique Protocol Identification Number

NCT02735876

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Withdrawn

Study Start Date

May 2016 (undefined)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acerta Pharma BV

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mantle Cell Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acalabrutinib plus rituximab

Arm Type

Experimental

Arm Description

Arm Title

ibrutinib

Arm Type

Active Comparator

Arm Description

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

Arm Title

acalabrutinib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

acalabrutinib

Intervention Type

Drug

Intervention Name(s)

ibrutinib

Intervention Type

Drug

Intervention Name(s)

rituximab

Primary Outcome Measure Information:

Title

Time Frame

48 months

Secondary Outcome Measure Information:

Title

Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Time Frame

48 months

Title

Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Time Frame

48 months

Title

Overall survival (OS).

Time Frame

48 months

Title

IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).

Time Frame

48 months

Other Pre-specified Outcome Measures:

Title

Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation.

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandeep Inamdar, MBBS

Organizational Affiliation

Acerta Pharma, LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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