Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Amino Acids

Acalabrutinib

Bendamustine Hydrochloride

Rituximab

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Bendamustine

Placebo

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.

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).

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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.

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.

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.

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.

Defined as the time from randomization until the date of death from any cause.

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.

Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV

Spots Global Cancer Trial Database for bendomustine

Every month we try and update this database with for bendomustine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.