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Trial record 30 of 51 for:    acalabrutinib

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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ClinicalTrials.gov Identifier: NCT02735876
Recruitment Status : Withdrawn
First Posted : April 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

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).

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: acalabrutinib Drug: ibrutinib Drug: rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: acalabrutinib plus rituximab
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: acalabrutinib
Drug: rituximab
Active Comparator: ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).
Drug: ibrutinib
Experimental: acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).
Drug: acalabrutinib



Primary Outcome Measures :
  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. [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]
  2. Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]
  3. Overall survival (OS). [ Time Frame: 48 months ]
  4. IRC-assessed duration of response (DOR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). [ Time Frame: 48 months ]

Other Outcome Measures:
  1. Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events (AEs) leading to treatment discontinuation. [ Time Frame: 48 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02735876


Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Sandeep Inamdar, MBBS Acerta Pharma, LLC

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02735876     History of Changes
Other Study ID Numbers: ACE-LY-309
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
ACP-196
Mantle Cell Lymphoma
MCL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents