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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Durvalumab

    Biological/Vaccine

    Given IV

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Lenalidomide

    Drug

    Given PO

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Arm I (durvalumab)Experimental treatment 2 interventions
Group B: Arm II (durvalumab, lenalidomide)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

CTCL specific response assessed by Lugano Classification

CTCL response was used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool was used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification was used.

Time frame
Up to 12 months
2

Dose limiting toxicity assessed by CTCAE version 4.03

Observed toxicities was summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

Time frame
Up to 84 days
3

Duration of Complete Response

Duration of complete response (CR) was defined as the time interval from the date of first documented complete response to the date of first documented disease relapse, progression or death whichever occurs first.

Time frame
Date when criteria for CR first met until time of loss of CR (relapse/recurrence) or death (as a result of MF/SS or acute toxicity of treatment), assessed up to 12 months
4

Event-Free Survival

Event-free survival was defined as the time interval from date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first. Event-free survival was estimated using the product-limit method of Kaplan and Meier.

Time frame
From date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, assessed up to 12 months

Secondary outcomes

1

Clinically Meaningful Reduction in Pruritus (CMRP)

CMRP was defined as a decrease in VAS score of at least 30 for at least two consecutive cycles for patients with moderate-to-severe pruritus at baseline. Changes in pruritus VAS score was assessed using descriptive statistics.

Time frame
Baseline up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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