Health Trials

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

ConditionsFolliculotropic Mycosis FungoidesRecurrent Cutaneous T-Cell Non-Hodgkin LymphomaRecurrent Mycosis FungoidesRefractory Cutaneous T-Cell Non-Hodgkin LymphomaRefractory Mycosis FungoidesRefractory Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedSezary SyndromeRecurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.

Eligibility criteria

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Registered into Revlimid REMS program

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1

Disqualifiers

Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines

Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs)

Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy

Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy

Trial design

Treatments tested in this trial

  • Durvalumab
  • Laboratory Biomarker Analysis
  • Lenalidomide

Treatment groups

78 Participants
are divided into 2 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov