NCT02735876

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).

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Last Updated

May 13, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

April 8, 2016

Last Update Submit

May 12, 2016

Conditions

Mantle Cell Lymphoma

Keywords

Bruton tyrosine kinase inhibitorBtkACP-196Mantle Cell LymphomaMCL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Outcomes (1)

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

    48 months

Study Arms (3)

acalabrutinib plus rituximab

EXPERIMENTAL

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).

Drug: acalabrutinibDrug: rituximab

ibrutinib

ACTIVE COMPARATOR

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

Drug: ibrutinib

acalabrutinib

EXPERIMENTAL

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

Drug: acalabrutinib

Interventions

acalabrutinibDRUG
acalabrutinibacalabrutinib plus rituximab
ibrutinibDRUG
ibrutinib
rituximabDRUG
acalabrutinib plus rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

acalabrutinibibrutinibRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sandeep Inamdar, MBBS

    Acerta Pharma, LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 13, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2020

Last Updated

May 13, 2016

Record last verified: 2016-04