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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Recurrent B-Cell Non-Hodgkin Lymphoma trials