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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    546
  • sponsor
    Acerta Pharma BV
Updated on 30 July 2020
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rituximab
bendamustine
acalabrutinib
cyclin d1

Summary

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.

Details
Treatment Acalabrutinib in combination with bendamustine and rituximab, Placebo in combination with bendamustine and rituximab
Clinical Study IdentifierNCT02972840
SponsorAcerta Pharma BV
Last Modified on30 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Gender: Male or Female
Do you have Mantle cell lymphoma?
Men and women, 65 years of age
Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5)
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 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
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