Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas

Summary

This is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.

Conditions

• Diffuse Large B-Cell Lymphoma
• High Grade B-Cell Lymphoma

Interventions

DRUG

Venetoclax

Venetoclax will be administered orally on days 3-12 in cycle 1, and days 1-10 with all subsequent cycles except dose level -1. If dose level -1 is required, venetoclax will be administered on days 3-7 in cycle 1 and 1-5 with subsequent cycles.

DRUG

Rituximab

Rituximab will be administered as an IV infusion at 375 mg/m2 on day 1 of each cycle of DA-EPOCH-R, immediately prior to the start of chemotherapy. Oral pre-medication 650 mg of acetaminophen and 50-100 mg diphenhydramine hydrochloride will be administered 30 to 60 minutes prior to starting each infusion of rituximab. The first rituximab infusion should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr. If this rate of escalation is well tolerated the second and subsequent infusions can begin at a rate of 100 mg/hr and increase in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. CAUTION: DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.

DRUG

Etoposide

Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUG

Vincristine Sulfate

Vincristine Sulfate will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUG

Cyclophosphamide

Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUG

Prednisone

Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.

DRUG

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• Massachusetts General Hospital

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• John P. Leonard, M.D. · Weill Medical College of Cornell University

• Jeremy S. Abramson, M.D. · Massachusetts General Hospital

• Sarah Rutherford, M.D. · Weill Medical College of Cornell University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-06

Primary Completion

2021-11-11

Completion

2021-11-11

FDA Drug

Yes

Countries

• United States

Study Locations