Immunotherapy and chemo join forces against tough lymphoma
NCT ID NCT03011814
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 5 times
Summary
This study tests two drugs—durvalumab (an immunotherapy) and lenalidomide (a chemotherapy drug)—alone or together in people with T-cell lymphoma that has returned or not responded to prior treatment. The goal is to find the best dose and see how well the combination works. About 78 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (an immunotherapy drug) and lenalidomide (a chemotherapy drug)
- What this could lead to
- If successful, this could offer a new treatment option for people with T-cell lymphoma that has stopped responding to other therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits and risks are not yet fully known. The combination may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2017
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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M D Anderson Cancer Center
WITHDRAWNHouston, Texas, 77030, United States
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Memorial Sloan-Kettering Cancer Center
WITHDRAWNNew York, New York, 10065, United States
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Thomas Jefferson University Hospital
WITHDRAWNPhiladelphia, Pennsylvania, 19107, United States
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