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A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

NCT02529852 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-09-19

Study results available
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Summary

There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion).

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma.

The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease.

The safety of this drug combination will be studied in both parts.

Conditions

Interventions

DRUG

Lenalidomide

Phase I Starting Dose Level: 15 mg by mouth on Days 1 - 14 of each 21 day cycle. Phase II Starting Dose Level: Maximum tolerated dose from Phase I.

DRUG

Obinutuzumab

Phase I and II: 1000 mg by vein on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 - 6.

DRUG

Cyclophosphamide

Phase I and II: 750 mg/m2 vein over about 1 hour on Day 1 of all cycles.

DRUG

Doxorubicin

Phase I and II: 50 mg/m2 by vein over about 15 minutes each on Day 1 of all cycles.

DRUG

Vincristine

Phase I and II: 1.4 mg/m2 by vein on Day 1 of all cycles.

DRUG

Prednisone

Phase I and II: 100 mg by mouth daily on Days 1 - 5 of each 21 day cycle.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jason R. Westin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02529852 on ClinicalTrials.gov