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

Summary

This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.

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.

Sponsors & Collaborators

• Acerta Pharma BV

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Brad S Kahl, M.D. · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-29

Primary Completion

2020-02-09

Completion

2025-04-14

FDA Drug

Yes

Countries

• United States

Study Locations