CompletedPhase 1

Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

United States106 participantsStarted 2013-10-17

Plain-language summary

This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.

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.

1. Documentation of Disease: 1. Histologically documented mantle cell lymphoma, with the following immunophenotypic characteristics: cluster of differentiation (CD)5+, (CD)23-, cyclin D1+; this may be from an initial diagnostic biopsy, or one obtained at time of relapse 2. Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen expression, lack of CD23 antigen expression, and expression of cyclin D1. 3. Variant cases of mantle cell lymphoma will be eligible to participate after discussion and joint agreement between the PI, the Pathology Committee Chair, and the Lymphoma Committee Chair. Variant cases may include (but are not limited to) lack of Cyclin D1 expression (ie cases with Cyclin D2 or Cyclin D3 expression), CD23 negativity (if all other criteria are met), or alternative translocations leading to Cyclin D1 expression. 2. Prior Treatment - Patients must have prior treatment with at least one regimen, which may have been single agent or multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents. Patient must not have received prior idelalisib or lenalidomide therapy. Patient must have progressive disease or refractory disease. Refractory disease will be defined as stable disease (SD) or progressive disease (PD) as best response to prior therapy. Progressive disease will be defined as complete response (CR) or partial response (PR) as initial response to prior therapy followed by disease progression within 6 mont…

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.

1Since this was a Phase 1 trial focused on finding the safest dose of idelalisib combined with lenalidomide, what do the results tell us about the side effect profile of this combination, and would those risks be acceptable given my specific health situation?
2This trial has already completed — does my doctor know what the maximum tolerated dose findings were, and is there a follow-on Phase 2 study or a newer trial building on these results that might be more appropriate for me to consider now?
3Both lenalidomide and idelalisib can affect the immune system in significant ways — given that I have relapsed or refractory mantle cell lymphoma, how does the risk profile of this combination compare to other options currently available to me?
4Since progression-free survival was a key thing being measured, has my doctor seen any published data from this trial suggesting whether the combination showed a meaningful benefit over lenalidomide alone, and how would that inform our decision?
5Before considering a completed trial like this one, would my doctor recommend I first explore standard second-line treatments — such as BTK inhibitors — and how does this combination fit into the broader landscape of options for relapsed or refractory mantle cell lymphoma?

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

Maximum tolerated dose (MTD) of idelalisib and lenalidomide, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

Timeframe: 28 days

Progression Free Survival (PFS) of the combination of lenalidomide, with or without idelalisib (Phase II)

Timeframe: Time between registration and disease progression or death, assessed up to 2 years

Trial details

NCT IDNCT01838434

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09-30

View on ClinicalTrials.gov More Relapsed/Refractory Mantle Cell Lymphoma trials