AzTrials
AzTrials

Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 2NCT02232516

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma

A Phase 2 study testing romidepsin, lenalidomide and laboratory biomarker analysis in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Northwestern University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
romidepsin, lenalidomide and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesUnited States
Study dates
11 Jun 2015to 16 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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
Show all 36Show fewer
  • 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

Who cannot join

  • 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])
Show all 23Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • City of Hope

    Duarte, California, 91010

  • Yale University

    New Haven, Connecticut, 06520

  • Weill Cornell Medicine

    New York, New York, 10021

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL

The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients with previously untreated peripheral T-cell lymphoma (PTCL).

SECONDARY OBJECTIVES:

  1. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further evaluate efficacy of the combination of romidepsin and lenalidomide.

III. Evaluate the delay to cytotoxic chemotherapy.

TERTIARY OBJECTIVES:

  1. Evaluate the use of Northwestern Medicine (NM) positron emission tomography (PET)/computed tomography (CT) vs CT imaging in PTCL.

II. Validate a new prognostic model for newly diagnosed PTCL. III. Investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15 and lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression, inter-current illness that prevents further administration of treatment, unacceptable toxicity, patient decides to withdraw from study treatment (or study as a whole), or general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the treating investigator.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 3 years.

Being tested
romidepsin, lenalidomide, laboratory biomarker analysis
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

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

  • romidepsinDrug

    Also called FK228, FR901228, Istodax

    Given IV

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02232516
Study groupRoleWhat they receive
Treatment (romidepsin, lenalidomide)ExperimentalPatients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Receives: Drug: romidepsin; Drug: lenalidomide; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective Response Rate (ORR), as Defined Per Cheson Criteria

    The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.

    Measured: Assessed after cycles 3 and 6, then every 6 months up to 3 years

Secondary outcomes (5)

  1. Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution. Grade 3 or greater AEs that occurred in at least 10% of the patients are reported here

    Measured: Evaluated once per cycle (1 cycle=28 days) up to 1 year.

  2. Progression-free Survival (PFS)

    l be progression-free survival (PFS)

    1 and 3 years after start of treatment as well as the duration of response from start of therapy, defined per Cheson criteria.

    Measured: Reported at 1 and 3 years after the start of treatment

  3. Overall Survival (OS)

    Survival is defined as the duration of time from start of treatment to time of death, up to three years from the start of study treatment. Overall Survival (OS) is reported below as the proportion of patients who are alive at 1 and 2 years after starting treatment.

    Measured: Reported at 1 and 2 years after the start of treatment

  4. Duration of Response, Defined Per Cheson Criteria

    The duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

    Measured: Assessed from start of therapy for up to 3 years

  5. Delay to Cytotoxic Chemotherapy

    Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma.

    Measured: Up to 1 year

Timeline

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

  1. First posted5 Sep 2014 (estimated)
  2. Study start11 Jun 2015
  3. Primary completion11 Aug 2020
  4. Study completion16 Mar 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02232516
Sponsor's protocol ID
NU 14H04
Other IDs
NCI-2014-01770, RV-CL-PTCL-PI-003974, STU00097620, P30CA060553
Status last verified
May 2026
First submitted
3 Sep 2014
Last updated
12 Jun 2026
Data monitoring committee
Yes

Publications

  • Ruan J, Zain J, Palmer B, Jovanovic B, Mi X, Swaroop A, Winter JN, Gordon LI, Karmali R, Moreira J, Petrich AM, Pro B. Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma. Blood Adv. 2023 Oct 10;7(19):5771-5779. doi: 10.1182/bloodadvances.2023009767.

    PubMed 37327113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing romidepsin, lenalidomide and laboratory biomarker analysis in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Northwestern University at 5 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 36 inclusion and 23 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 10 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR), as Defined Per Cheson Criteria (time frame: Assessed after cycles 3 and 6, then every 6 months up to 3 years). 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 NCT02232516, which also lists 1 linked publication.

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 12 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in