Recruiting
Phase 1
Phase 2

Durvalumab & Lenalidomide

Sponsor:

City of Hope Medical Center

Code:

NCT03011814

Conditions

Folliculotropic Mycosis Fungoides

Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma

Recurrent Mycosis Fungoides

Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma

Refractory Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Durvalumab

Laboratory Biomarker Analysis

Lenalidomide

Study Details

Brief summary:

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.

Conditions

Folliculotropic Mycosis Fungoides

Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma

Recurrent Mycosis Fungoides

Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma

Refractory Mycosis Fungoides

Study ID

NCT03011814

Start date

Mar 8, 2017

Status verified date

Jul, 2026

Completion date

Apr 14, 2030

Anticipated

Primary completion date

Apr 14, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (durvalumab)

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.

experimental: Arm II (durvalumab, lenalidomide)

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.

Interventions

Durvalumab

Given IV

Laboratory Biomarker Analysis

Correlative studies

Lenalidomide

Given PO

Primary outcome measure

  • CTCL specific response assessed by Lugano Classification [ Time Frame: Up to 12 months ]
  • Dose limiting toxicity assessed by CTCAE version 4.03 [ Time Frame: Up to 84 days ]
  • Duration of Complete Response [ 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 ]
  • Event-Free Survival [ 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 ]
  • Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03 [ Time Frame: Up to 90 days post-treatment ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
  • Overall survival (OS) [ Time Frame: From date of first dose of study drug to date of death from any cause, assessed up to 12 months ]
  • Progression Free Survival (PFS) [ Time Frame: Date of initiation of treatment to first date meets criteria for progressive disease or death as a result of any cause, assessed up to 12 months ]
  • Response duration [ Time Frame: From the date of first documented response to the date of first documented disease relapse, progression or death whichever occurs first, assessed up to 12 months ]
  • Time to response [ Time Frame: Date of initiation of treatment to date when criteria for response (PR or CR) first met, assessed up to 12 months ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Christiane Querfeld, MD

626-256-4673cquerfeld@coh.org

Principal Investigator:

Christiane Querfeld, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-31.