Trials / Withdrawn

WithdrawnNCT04635683

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

A Phase I Trial of Lenalidomide, Umbralisib and Ublituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Status: Withdrawn
Phase: Phase 1
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Yazeed Sawalha · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the recommended phase 2 dose (RP2D) and toxicity of lenalidomide, umbralisib and ublituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. Determine the overall response rate (ORR) for patients with relapsed or refractory follicular lymphoma (FL) treated at the RP2D. II. Determine duration of response (DOR), progression-free survival (PFS), time to treatment failure and overall survival (OS) for patients with relapsed or refractory FL treated at the RP2D. OUTLINE: This is a dose-escalation study of lenalidomide and umbralisib. Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and umbralisib PO QD on days 1-28. Beginning in cycle 2, patients also receive ublituximab intravenously (IV) over 90 minutes to 4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial or complete response after cycle 6 continue treatment of lenalidomide PO QD and umbralisib PO QD for 12 additional cycles, and ublituximab IV on day 1 of subsequent even cycles (8, 10, 12, 14, 16, and 18). Patients with stable disease after cycle 6 may continue on treatment for an additional 12 cycles at the discretion of the investigator. After completion of study treatment, patients are followed up within 8 weeks, and then every 6 months for 2 years.

Conditions

Interventions

Type	Name	Description
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Ublituximab	Given IV
DRUG	Umbralisib	Given PO

Timeline

Start date: 2022-09-30
Primary completion: 2023-12-31
Completion: 2024-12-31
First posted: 2020-11-19
Last updated: 2022-09-30

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04635683. Inclusion in this directory is not an endorsement.