TriangleNCT02972840 · CITED IN SOURCE DOCUMENTS
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-06-01
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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.
- healthy Volunteers
- false
- minimum Age
- 65 Years
- sex
- ALL
- std Ages
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Acalabrutinib
- Drug: Bendamustine
- Drug: Rituximab
- label
- Acalabrutinib in combination with bendamustine and rituximab
- type
- EXPERIMENTAL
- description
- Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
- intervention Names
- Drug: Bendamustine
- Drug: Rituximab
- Drug: Placebo
- label
- Placebo in combination with bendamustine and rituximab
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Acalabrutinib in combination with bendamustine and rituximab
- description
- Administered orally (PO)
- name
- Acalabrutinib
- other Names
- ACP-196
- Calquence
- type
- DRUG
- arm Group Labels
- Acalabrutinib in combination with bendamustine and rituximab
- Placebo in combination with bendamustine and rituximab
- description
- Administered intravenously (IV)
- name
- Bendamustine
- other Names
- Treanda
- Bendeka
- type
- DRUG
- arm Group Labels
- Acalabrutinib in combination with bendamustine and rituximab
- Placebo in combination with bendamustine and rituximab
- description
- Administered intravenously (IV)
- name
- Rituximab
- other Names
- Rituxan
- Rituxan Hycela
- type
- DRUG
- arm Group Labels
- Placebo in combination with bendamustine and rituximab
- description
- Placebo comparator
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 635
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
- measure
- Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- secondary Outcomes
- description
- Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
- measure
- Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- description
- Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.
- measure
- Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- description
- Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.
- measure
- IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- description
- Defined as the time from randomization until the date of death from any cause.
- measure
- Overall survival in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- description
- Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.
- measure
- IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
- description
- Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
- measure
- IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
- time Frame
- Up to 6 years
Full study description
- brief 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.
- detailed Description
- To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).
Source references
- references
- citation
- Wang M, Salek D, Belada D, Song Y, Jurczak W, Kahl BS, Paludo J, Chu MP, Kryachok I, Fogliatto L, Cheah CY, Morawska M, Sancho JM, Li Y, Patti C, Forsyth C, Zhang J, Lesley R, Ramadan S, Rule S, Dreyling M; ECHO investigators; ECHO Investigators. Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma. J Clin Oncol. 2025 Jul 10;43(20):2276-2284. doi: 10.1200/JCO-25-00690. Epub 2025 May 1.
- pmid
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- type
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- O The efficacy of CALQUENCE in patients with previously untreated MCL was evaluated in a randomized, double-blind, placebo controlled, multicenter study (ECHO; NCT02972840). The study enrolled 598 patients who were ≥ 65 years of age and who had no intention for transplant. The study excluded patients with total bilirubin > 1.5 ×
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- posted on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in ECHO (NCT02972840), a randomized, double-blind, placebo controlled, multicenter trial in 598 patients with untreated MCL who were ≥65 years of age and not intended to receive HS
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Preserved source evidence · Not medical advice