At a glance
ClinicalIndex Comparison Record- ✓Relapsed/refractory disease
- ✓Failed ≥2 prior systemic therapies (ALCL must include brentuximab vedotin progression)
- ✓Histologically confirmed mycosis fungoides or Sezary syndrome (CTCL cohort)
- ✓CTCL Phase 1: ≥stage IIB or ≥stage IB-IIA folliculotropic/transformed MF; Phase 2: ≥stage IB
- ✕Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines
- ✕Prior lenalidomide, thalidomide, or other IMiDs
- ✕Monoclonal antibody within 5 half-lives prior to initiating therapy
- ✕Any systemic therapy within 28 days or 5 half-lives (whichever shorter) of initiating therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Trial of Durvalumab (MEDI4736) When Given as a Single Agent or in Combination With Lenalidomide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma, Including Cutaneous T-cell Lymphoma
In Brief
A Phase 1 clinical trial evaluating Durvalumab, Laboratory Biomarker Analysis, and 1 other intervention for Folliculotropic Mycosis Fungoides and 7 related conditions. Currently recruiting, targeting 78 participants across 4 sites.
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given PO