WithdrawnPhase 1

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

Stopped: Investigational Drug removed from the market

0Started 2022-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documentation of disease at diagnosis and/or relapse (local pathology review is allowed): * Patients in the dose-escalation portion of the study must have histologically confirmed, low-grade B-cell NHL by the World Health Organization (WHO) classification: * Follicular lymphoma (FL) grade 1, 2, or 3a * Marginal zone B-cell lymphoma (MZL), including extranodal, nodal and splenic * Lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia * Mantle cell lymphoma (MCL) * For the expansion cohort, patients must have histologically confirmed FL grade 1, 2, or 3a * Patients with FL or MZL must have had at least one prior systemic therapy. Patients with MCL or LPL/Waldenström macroglobulinemia must have had prior treatment with at least 2 systemic treatments that included a BTK inhibitor (stopped due to progression or intolerance). * Must be in need of treatment for relapsed or refractory disease as assessed by the investigator * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Patients must have radiographically measurable disease * Patients with LPL/Waldenstrom macroglobulinemia or MZL without radiographically measurable disease may be included if they have a measurable serum monoclonal protein (M protein) * Absolute neutrophil count (ANC) \> 1,000/mcL * Platelet count \> 75,000/mcL * Total bilirubin =\< 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease) * Aspartate aminotrans…

What they're measuring

Recommended phase 2 dose (RP2D)

Timeframe: Up to completion of cycle 2 (each cycle is 28 days)

Trial details

NCT IDNCT04635683

SponsorYazeed Sawalha

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31