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
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.
• 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 modified severity weighted assessment tool (mSWAT) and/or Sezary count
• 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
• 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
• If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =\< 1.5 x ULN
• \* If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants
• Female of childbearing potential: negative urine or serum pregnancy test
• \* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Female of child bearing potential: willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication
• \* Childbearing potential defined as not being surgically sterilized or have not been free from menses for \> 1 year
• Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy