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NCT03011814 · City of Hope Medical Center

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

What this study is about

This randomly assigned 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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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 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

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

  • Duarte, California
  • New York, New York
  • Philadelphia, Pennsylvania
  • Houston, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations

📊
1 of 78 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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RECRUITING

Duarte

California

Location available
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New York

New York

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Philadelphia

Pennsylvania

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Houston

Texas

Location available

Express your interest

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Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Folliculotropic Mycosis Fungoides Treatment in Duarte?

Join others in California exploring innovative treatment options through clinical research

Folliculotropic Mycosis Fungoides Treatment Options in Duarte, California

If you're searching for Folliculotropic Mycosis Fungoides treatment in Duarte, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Duarte, New York, Philadelphia and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Folliculotropic Mycosis Fungoides. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 78 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Folliculotropic Mycosis Fungoides?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Folliculotropic Mycosis Fungoides

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Folliculotropic Mycosis Fungoides Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03011814. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.