NCT04578600

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

A Phase I/IB Pilot Study of CC-486 Combined With Lenalidomide and Obinutuzumab for Relapsed/Refractory Indolent B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Joseph Tuscano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: To assess the safety and toxicity of oral azacitidine (CC-486) in combination with lenalidomide and obinutuzumab. SECONDARY OBJECTIVES: I. To evaluate the efficacy of CC-486 in combination with lenalidomide and obinutuzumab in subjects with relapsed/refractory indolent B-cell lymphoma as assessed by: Ia. Overall response rate: complete response (CR) + partial response (PR) per 2016 Lugano criteria and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) criteria. Ib. Duration of response (DOR): will be calculated from time of initial response assessment demonstrating at least PR until disease response assessment that demonstrates progressive disease. Ic. Time to response (TTR): calculated as time from registration to first disease response assessment that demonstrates at least PR. Id. Progression-free survival (PFS): Patients are considered a failure for this endpoint if they die or if they relapse/progress or receive additional anti-lymphoma therapy. Ie. Determine the recommended phase 2 dose (RP2D).

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

Type	Name	Description
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Obinutuzumab	Given IV
DRUG	Oral Azacitidine	Given PO

Timeline

• Start date: 2020-10-23
• Primary completion: 2023-12-12
• Completion: 2025-02-21
• First posted: 2020-10-08
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study