Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

November 29, 2018

Primary Completion Date

February 9, 2020

Study Completion Date

April 14, 2025

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Bendamustine

Bendamustine will be administered at a dose of 90 mg/m\^2 IV over 30 minutes on Days 1 and 2 of Cycles 1-3

DRUG

Rituximab

In Cycle 1, rituximab will be administered at a dose of 375 mg/m\^2 IV on Day 1 or 2 at the investigator's discretion in order to reduce the risk of a first infusion reaction. Rituximab will be given on Day 1 of Cycles 1 through 6.

DRUG

Acalabrutinib

The capsules should be swallowed intact with water and with or without food.

DRUG

Cytarabine

On Days 1 and 2 of Cycles 4-6, following rituximab dosing, cytarabine will be administered IV every 12 hours for a total of 4 doses.

PROCEDURE

Leukapheresis

Until collection of ≥ 2 x 106 CD34+ stem cells / kg

PROCEDURE

Peripheral blood

-Baseline, end of Cycle 3, 4-6 weeks after Cycle 6 Day 1, and if the patient discontinues protocol therapy prior to completion of Cycle 6

PROCEDURE

Oral rinse

-Baseline

PROCEDURE

Bone marrow collection

-Bone marrow will be collected at baseline if the patient requires a marrow for staging purposes and at end of treatment if the patient requires a marrow for restaging.

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Acerta Pharma BV

INDUSTRY

lead

Washington University School of Medicine

OTHER