NCT03011814.

Study name	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
Methods	This is a randomised, controlled, open‐label trial on durvalumab (MEDI4736) with or without lenalidomide in patients with cutaneous or peripheral T‐cell lymphoma
Participants	Inclusion criteria 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 at least 1 prior systemic therapy 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 fulfilment 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 Exclusion criteria 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
Interventions	Arm I 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 Arm II 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
Outcomes	Primary outcomes of the trial CTCL specific response assessed by Lugano Classification CTCL response will be used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool will be used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification will be used Dose limiting toxicity assessed by CTCAE version 4.03 Duration of complete response Event‐free survival Will be estimated using the product‐limit method of Kaplan and Meier Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03 Observed toxicities will be summarised in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. ORR defined as proportion of patients with complete response (CR) and partial response (PR) Overall survival Will be estimated using the product‐limit method of Kaplan and Meier Progression‐free survival Response duration 95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapies. Time to response Secondary outcomes of the trial Pruritus assessment Changes in pruritus VAS score will be assessed using descriptive statistics
Starting date	February 2017
Contact information	Sponsors and collaborators City of Hope Medical Center National Cancer Institute (NCI) Investigators Principal Investigator: Christiane Querfeld, MD City of Hope Medical Center
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