Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Summary

This phase I trial studies the safety and how effective the combination of ublituximab, umbralisib, and lenalidomide is in certain types of indolent (slow-growing) non-Hodgkin's lymphoma or mantle cell lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Umbralisib is designed to block a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune system that may allow the immune system to better act against cancer cells. Ublituximab is an antibody that attaches to the lymphoma cells and triggers immune reactions that may result in the death of the targeted lymphoma cells.

Conditions

• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Recurrent Follicular Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3a Follicular Lymphoma
• Recurrent Lymphoplasmacytic Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Nodal Marginal Zone Lymphoma
• Recurrent Splenic Marginal Zone Lymphoma
• Recurrent Waldenstrom Macroglobulinemia
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Refractory Follicular Lymphoma
• Refractory Grade 1 Follicular Lymphoma
• Refractory Grade 2 Follicular Lymphoma
• Refractory Grade 3a Follicular Lymphoma
• Refractory Lymphoplasmacytic Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Marginal Zone Lymphoma
• Refractory Nodal Marginal Zone Lymphoma
• Refractory Splenic Marginal Zone Lymphoma
• Refractory Waldenstrom Macroglobulinemia

Interventions

DRUG

Lenalidomide

Given PO

BIOLOGICAL

Ublituximab

Given IV

DRUG

Umbralisib

Given PO

Sponsors & Collaborators

• Yazeed Sawalha

  lead OTHER

Principal Investigators

• Yazeed Sawalha, MD · Ohio State University Comprehensive 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

2022-09-30

Primary Completion

2023-12-31

Completion

2024-12-31

FDA Drug

Yes