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A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma

This study is currently recruiting participants.
Verified September 2017 by Acerta Pharma BV
Sponsor:
ClinicalTrials.gov Identifier:
NCT02972840
First Posted: November 25, 2016
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Acerta Pharma BV
  Purpose
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Condition Intervention Phase
Lymphoma, Mantle Cell Drug: Acalabrutinib in combination with bendamustine and rituximab Drug: Placebo in combination with bendamustine and rituximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  • Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  • IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  • Overall survival in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  • IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]
  • IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]

Estimated Enrollment: 546
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: April 2023
Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acalabrutinib in combination with bendamustine and rituximab
Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Drug: Acalabrutinib in combination with bendamustine and rituximab
Acalabrutinib in combination with BR
Placebo Comparator: Placebo in combination with bendamustine and rituximab
Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Drug: Placebo in combination with bendamustine and rituximab
Placebo in combination with BR

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ≥ 65 years of age.
  • Pathologically confirmed MCL, with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
  • MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use highly effective forms of contraception during the study and 90 days after the last dose of acalabrutinib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .

Exclusion Criteria:

  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) > 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, 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 (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
  • Concurrent participation in another therapeutic clinical trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972840


Contacts
Contact: Rudy Narace 1650-591-2800 ext 176 ace-ly-308@acerta-pharma.com

  Show 36 Study Locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Shweta Gupta, BAMS, MD Acerta Pharma
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02972840     History of Changes
Other Study ID Numbers: ACE-LY-308
First Submitted: November 21, 2016
First Posted: November 25, 2016
Last Update Posted: October 5, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
ACP-196
Mantle Cell Lymphoma
acalabrutinib
ACE-LY-308
Treatment naive
Lymphoma
non-Hodgkins

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action