New drug cocktail aims to tackle rare blood cancer
NCT ID NCT02232516
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether combining two drugs, romidepsin and lenalidomide, is safe and effective for people with peripheral T-cell lymphoma (PTCL) who haven't had treatment yet. PTCL is a rare blood cancer with no standard therapy, and current options like CHOP chemotherapy are often hard to tolerate. The study enrolled 30 adults with various PTCL subtypes and measured how many patients responded to treatment, as well as any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- romidepsin and lenalidomide
- What this could lead to
- If successful, this combination could offer a more effective and tolerable treatment option for people with peripheral T-cell lymphoma who have not been treated before.
- What could go wrong
- This is a small, early-phase study with only 30 participants. The combination may cause significant side effects, and results may not apply to all types of PTCL.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jun 2015
- Finished
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Mar 2024
- Lead sponsor
-
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: * Histologically confirmed diagnosis of PTCL (using the most recent edition of the World Health Organization \[WHO\] Classification of Tumors of Hematopoietic and Lymphoid Tissues as guidance) including: * Anaplastic large cell lymphoma, anaplastic large cell kinase (ALK)-negative * Angioimmunoblastic T-cell lymphoma * Enteropathy-type T-cell lymphoma * Extranodal natural killer (NK)/T-cell lymphoma, nasal type * Hepatosplenic gamma-delta T-cell lymphoma * Peripheral T-cell lymphoma, unspecified (not otherwise specified \[NOS\]) * Transformed mycosis fungoides * Subcutaneous panniculitis-like T-cell lymphoma. * NOTE: Patients with adequate archived (well-preserved, formalin-fixed) biopsy tissue remaining will be required to submit a portion for exploratory studies; this is not optional if tissue is available; however, lack of adequate tissue for exploratory studies will not preclude patients from participating * Patients must have bi-dimensionally measurable disease (\>= 1 cm) by CT imaging * NOTE: Patients with marrow-only disease are eligible; response for these patients will be assessed by repeat bone marrow biopsy * Patients must fit into one of the following categories: * Age \>= 18 years to \< 60 years with a cumulative illness rating scale (CIRS) score \>= 6 OR deemed ineligible for cytotoxic chemotherapy by the treating investigator * \>= 60 years * Patients must have adequate organ and marrow function (documented within 14 days prior to registration) as outlined below: * Absolute neutrophil count (ANC) \>= 750/mcl * Hemoglobin \>= 8 g/dl * Platelets \>= 50,000/mcl * Total bilirubin =\< 2 x upper limit normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum pyruvate glutamate transaminase \[SPGT\]) =\< 3 x ULN * Creatinine =\< 2 x ULN * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * All patients must agree to use effective contraception while on study, and all patients must agree to undergo counseling sessions every 28 days about pregnancy precautions and risks of fetal exposure * Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least 28 days following discontinuation of lenalidomide therapy * Males receiving lenalidomide must agree to use a latex condom during any sexual contact with FCBPs even if they have undergone a successful vasectomy * NOTE: A FCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * FCBP should be referred to a qualified provider of contraceptive methods, if needed * FCPB must have a negative urine or serum pregnancy test within 7 days prior to registration, and be willing to adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS®) program * NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients must be free of any prior malignancies for \>= 1 year * NOTE: The exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excision * All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration Exclusion Criteria: * Patients with a diagnosis of any of the following are not eligible: * Anaplastic large cell lymphoma, ALK-positive * Adult T-cell lymphoma/leukemia (ATLL) * Anaplastic large-cell lymphoma, primary cutaneous type * Precursor T-lymphoblastic lymphoma/leukemia * Mycosis fungoides/Sezary syndrome (except transformed Mycosis fungoides \[MF\]) * NK-cell leukemia * T-cell granular lymphocytic leukemia * T-cell prolymphocytic leukemia * Patients must not have received prior systemic therapy for PTCL (except for corticosteroids for 10 or fewer days at any dose, no washout period required as long as they discontinue prior to starting study therapy); NOTE: topical treatment may have been given for prior existence of cutaneous lymphoma that has since become systemic PTCL; however, these topical therapies should be stopped at time of registration * Patients who received chemotherapy (including monoclonal antibodies) or radiotherapy, administered for any condition, within 4 weeks prior to registration are not eligible * Patients who received prior exposure to any other histone deacetylase (HDAC) inhibitors or immunomodulatory (IMID) agents for any reason are not eligible * Patients receiving ongoing treatment with any other investigational agents are not eligible * Patients who have known central nervous system (CNS) involvement of lymphoma are not eligible * Patients who have an uncontrolled intercurrent illness including, but not limited to, any of the following are not eligible: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Patients with a known human immunodeficiency (HIV) infection are not eligible * Patients who are pregnant or actively nursing an infant are not eligible * Patients with a QT interval \> 500 msec (using the Bazett's formula) within 28 days prior to registration are not eligible
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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.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Weill Cornell Medicine
New York, New York, 10021, United States
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Yale University
New Haven, Connecticut, 06520, United States
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