CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma

Summary

This phase I/Ib trial investigates the side effects of CC-486 and how well it works in combination with lenalidomide and obinutuzumab in treating patients with CD20 positive B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Chemotherapy drugs, such as CC-486, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide is a drug that alters the immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Obinutuzumab is a type of antibody therapy that targets and attaches to the CD20 proteins found on follicular lymphoma cells as well as some healthy blood cells. Once attached to the CD20 protein the obinutuzumab is thought to work in different ways, including by helping the immune system destroy the cancer cells and by destroying the cancer cells directly. Giving CC-486 with lenalidomide and obinutuzumab may improve response rates, quality, and duration, and minimize adverse events in patients with B-cell lymphoma.

Conditions

• Indolent B-Cell Non-Hodgkin Lymphoma
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Mucosa-Associated Lymphoid Tissue Lymphoma
• Recurrent Follicular Lymphoma
• Recurrent Hairy Cell Leukemia
• Recurrent Lymphoplasmacytic Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Mucosa-Associated Lymphoid Tissue Lymphoma
• Refractory Follicular Lymphoma
• Refractory Hairy Cell Leukemia
• Refractory Lymphoplasmacytic Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Marginal Zone Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Refractory Small Lymphocytic Lymphoma

Interventions

DRUG

Lenalidomide

Given PO

BIOLOGICAL

Obinutuzumab

Given IV

DRUG

Oral Azacitidine

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Celgene

  collaborator INDUSTRY

• Joseph Tuscano

  lead OTHER

Principal Investigators

• Joseph M Tuscano · University of California, Davis

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-23

Primary Completion

2023-12-12

Completion

2025-02-21

FDA Drug

Yes

Countries

• United States

Study Locations