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Folliculotropic Mycosis FungoidesPhase 1/2NCT03011814

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

A Phase 1/2 study testing Durvalumab, Laboratory Biomarker Analysis and Lenalidomide in people with Folliculotropic Mycosis Fungoides and Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Laboratory Biomarker Analysis and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
4 sitesUnited States
Study dates
8 Mar 2017to 14 Apr 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Christiane Querfeld, MD, 626-256-4673, cquerfeld@coh.org

    Christiane Querfeld, MD

    Recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Withdrawn

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Withdrawn

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Withdrawn

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (recommended phase 2 dose, RP2D) of lenalidomide, when given in combination with fixed-dose durvalumab. (Phase 1) II. To assess the safety and tolerability of the lenalidomide/durvalumab regimen, and accompanying dose modification plan, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase 1) III. To evaluate the anti-tumor activity durvalumab (MEDI4736) as single agent therapy and as part of combination therapy (+lenalidomide); activity assessed by overall response rate (ORR). (Phase 2)

SECONDARY OBJECTIVES:

  1. To estimate and assess response duration and survival probabilities (overall and event-free). (Phase 2) II. To summarize and assess toxicities by type, frequency, severity, attribution, time course and duration. (Phase 2) III. To assess clinically meaningful reduction in pruritus (CMRP) in patients with CTCL (critical quality of life measure). (Phase 2)

TERTIARY OBJECTIVES:

  1. To identify the malignant CD4+ T cells within the skin microenvironment. II. To characterize the spatial and functional relationship of malignant T cells with other immune cells, their expression of key immune checkpoints and correlate with response.

III. To identify aberrantly expressed micro(mi) ribonucleic acid (RNA)s involved in cutaneous T-cell lymphoma (CTCL) and messenger (m)RNAs that may predict response and/or treatment-related toxicity.

IV. To evaluate whether or not the identified miRNAs are involved in regulating key immune checkpoints.

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients are randomized to 1 of 2 arms,

ARM I: Patients receive durvalumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 28 days (+/- 3) 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 orally (PO) once daily (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.

After completion of study treatment, patients are followed up for up to 12 months.

Being tested
Durvalumab, Laboratory Biomarker Analysis, Lenalidomide
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Lymphoma, T-Cell, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabBiological

    Also called Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

Study groups in NCT03011814
Study groupRoleWhat they receive
Arm I (durvalumab)ExperimentalPatients 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.
Receives: Biological: Durvalumab; Other: Laboratory Biomarker Analysis
Arm II (durvalumab, lenalidomide)ExperimentalPatients 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.
Receives: Biological: Durvalumab; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CTCL specific response assessed by Lugano Classification

    CTCL response was used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool was used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification was used.

    Measured: Up to 12 months

  2. Dose limiting toxicity assessed by CTCAE version 4.03

    Observed toxicities was summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

    Measured: Up to 84 days

  3. Duration of Complete Response

    Duration of complete response (CR) was defined as the time interval from the date of first documented complete response to the date of first documented disease relapse, progression or death whichever occurs first.

    Measured: 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

  4. Event-Free Survival

    Event-free survival was defined as the time interval from date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first. Event-free survival was estimated using the product-limit method of Kaplan and Meier.

    Measured: 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

  5. Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03

    Observed toxicities was summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

    Measured: Up to 90 days post-treatment

  6. Overall Response Rate (ORR)

    ORR was defined as proportion of patients with complete response (CR) and partial response (PR). The overall response rate and 95% Clopper Pearson binomial confidence interval (CI) was calculated.

    Measured: Up to 12 months

  7. Overall survival (OS)

    OS was defined as the time interval from date of first dose of study drug to date of death from any cause. OS was estimated using the product-limit method of Kaplan and Meier.

    Measured: From date of first dose of study drug to date of death from any cause, assessed up to 12 months

  8. Progression Free Survival (PFS)

    PFS was date of initiation of treatment to first date meets criteria for PD or death as a result of any cause.

    Measured: 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

  9. Response duration

    95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapies.

    Measured: 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

  10. Time to response

    Measured: Date of initiation of treatment to date when criteria for response (PR or CR) first met, assessed up to 12 months

Secondary outcomes (1)

  1. Clinically Meaningful Reduction in Pruritus (CMRP)

    CMRP was defined as a decrease in VAS score of at least 30 for at least two consecutive cycles for patients with moderate-to-severe pruritus at baseline. Changes in pruritus VAS score was assessed using descriptive statistics.

    Measured: Baseline up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study start8 Mar 2017
  3. Primary completion14 Apr 2030 (estimated)
  4. Study completion14 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011814
Sponsor's protocol ID
16221
Other IDs
NCI-2016-02061, 16221, R01CA229510
Status last verified
Jul 2026
First submitted
4 Jan 2017
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Querfeld C, Palmer J, Han Z, Wu X, Yuan YC, Chen MH, Su C, Tsai NC, Smith DL, Hammond SN, Crisan L, Song JY, Pillai R, Rosen ST, Zain J. Phase 1 trial of durvalumab (anti-PD-L1) combined with lenalidomide in relapsed/refractory cutaneous T-cell lymphoma. Blood Adv. 2025 May 13;9(9):2247-2260. doi: 10.1182/bloodadvances.2024014655.

    PubMed 39951620

  • Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

    PubMed 32632956

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab, Laboratory Biomarker Analysis and Lenalidomide in people with Folliculotropic Mycosis Fungoides and Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTCL specific response assessed by Lugano Classification (time frame: Up to 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03011814, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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