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

Recruiting now · Phase 1/Phase 2

Conditions studied: Folliculotropic Mycosis Fungoides, Recurrent Cutaneous T-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, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma

In brief

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 facts

Study ID

NCT03011814

Run by

City of Hope Medical Center

People needed

78

Starts

2017-03-08

Expected to finish

2030-04-14

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Stage of disease according to TNMB classification
• Pathology report must be diagnostic or be consistent with MF/SS criteria
• SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
• For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used
• Measurable disease per either mSWAT, Sezary count, or Lugano Classification (Section 11.2)
• Baseline skin biopsy taken within 6 months available for central review submission
• PERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY
• Histologically confirmed PTCL as defined by World Health Organization (WHO) 2008 criteria
• Measurable and/or evaluable disease per Lugano Classification (Section 11.2)
• Absolute neutrophil count (ANC) >= 1000/mm\^3
• Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
• Platelets >= 100,000/mm\^3
• Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
• Total serum bilirubin =< 2.2 mg/dL
• Aspartate aminotransferase (AST) =< 2 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) =< 2 x ULN
• Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula

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
• Systemic corticosteroids at physiologic doses of < 10 mg/day of prednisone or equivalent
• Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy
• History of pneumonitis (non-infectious) that required steroids or current pneumonitis
• Disease free of prior malignancies for >= 5 years with the exception of:
• Currently treated squamous cell and basal cell carcinoma of the skin
• Carcinoma in situ of the cervix, or
• Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or
• Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or
• Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
• Allergic reaction/ hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab
• Female only: pregnant or lactating
• Prior stem cell transplantation
• Acute infection requiring systemic treatment
• Known history of human immunodeficiency virus (HIV) infection
• Active hepatitis B or C infection
• Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
• Current peripheral neuropathy >= grade 2

Where it is running

• City of Hope Medical Center — Duarte, California, United States (enrolling)
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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