Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ 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
- ✓ Relapsed/refractory disease
- ✓ Failed \>= 2 prior systemic therapies \*NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin
- ✓ CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY
- ✓ Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: \>= stage IIB OR \>= stage IB-IIA folliculotropic/transformed MF; Phase 2: \>= stage IB
You may not qualify if…
- ✕ 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
- ✕ Any skin-directed therapy within 14 days prior to initiating protocol therapy
- ✕ Any radiation therapy within 21 days prior to initiating protocol therapy
- ✕ Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion:
- ✕ Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
Where it's recruiting
Source: ClinicalTrials.gov · NCT03011814 · last updated 2026-07-31