Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Durvalumab With or Without Lenalidomide for Relapsed/Refractory Cutaneous or Peripheral T-Cell Lymphoma

Official title: 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

Run by City of Hope Medical Center · NCT03011814 · Data updated 2026-11-12

This study tests whether adding lenalidomide to durvalumab is safe and helps treating relapsed or refractory cutaneous or peripheral T-cell lymphoma.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment78 (estimated)
SponsorCity of Hope Medical Center
Academic / other
Drugs / interventionsbrentuximab, durvalumab, Immunotherapy, radiation, prednisone, chemotherapy
Locations4 sites (Duarte, California and 3 other locations)
StatusRecruiting
StartedMarch 8, 2017
Main results expectedApril 14, 2030
Study endsApril 14, 2030
Registry record updatedJuly 31, 2026
Trial IDNCT03011814 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with relapsed or refractory MF/SS or other CTCLs, adequate organ function, ECOG 0-2, and eligibility to receive durvalumab and lenalidomide.

Probably not a fit

Patients with disease progression or intolerable toxicity, inability to enroll in REMS programs, or inadequate organ function may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, randomized trial evaluating the highest tolerable dose and safety of lenalidomide given with a fixed dose of durvalumab, and the anti-tumor activity of durvalumab alone and in combination. The trial includes patients with relapsed or refractory cutaneous T-cell lymphomas, such as mycosis fungoides and Sezary syndrome, who have failed prior therapies. Primary goals include determining the recommended phase 2 dose of lenalidomide and assessing regimen safety and tolerability, as well as measuring overall response rate. Secondary aims cover response duration, survival probabilities, and toxicity profiles, along with quality-of-life measure related to itching. Tertiary objectives focus on immune cell dynamics in the skin and molecular markers that may predict response or toxicity.

Why it matters

Potential benefit: If successful, the regimen could provide another treatment option that slows disease and improves symptoms for patients with relapsed or refractory CTCL.

How similar studies have gone: Previous studies in similar immune-based approaches have shown activity in CTCL, but combining durvalumab with lenalidomide is being explored for potential added benefit.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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
* 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

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
* 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
* Renal failure requiring hemodialysis or peritoneal dialysis
* Unstable cardiac disease as defined by one of the following:

  * Cardiac events such as myocardial infarction (MI) within the past 6 months
  * NYHA (New York Heart Association) heart failure class III-IV
  * Uncontrolled atrial fibrillation or hypertension
* Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
* Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:

  * Vitiligo or alopecia;
  * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or
  * Psoriasis not requiring systemic treatment
* History of primary immunodeficiency
* Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide
* Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
* In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it's running

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

Study contacts

  • Principal investigator: Christiane Querfeld, MD — City of Hope Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.