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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03011814
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Folliculotropic Mycosis Fungoides
  • Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides
  • Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Sezary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lenalidomide — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
Jan 5, 2017
Start date
Mar 8, 2017
Status verified
Jul 2026
Primary completion
Apr 14, 2030
Completion
Apr 14, 2030

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (durvalumab)
    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.
  • Experimental: Arm II (durvalumab, lenalidomide)
    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.

Primary Outcome Measure

CTCL specific response assessed by Lugano Classification [ Time Frame: Up to 12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Christiane Querfeld, MD
[email protected]
626-256-4673
Christiane Querfeld, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAMemorial Sloan-Kettering Cancer Center· New York, NYThomas Jefferson University Hospital· Philadelphia, PAM D Anderson Cancer Center· Houston, TX

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