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T Cell Non-Hodgkin LymphomaPhase 2NCT01908777

A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma

A Phase 2 study testing High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin in people with T Cell Non-Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
T Cell Non-Hodgkin Lymphoma
What is being tested?
High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
10 sitesUnited States
Study dates
16 Jul 2013to 3 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age: Patients over age 16 who are deemed eligible for transplant by their treating physician Disease status: CR or PR required. Remission status will be assessed at the completion of induction chemotherapy and prior to enrollment on protocol.
  • Diagnosis: The following histologies will need to be confirmed at MSK or locally for participating sites in order to be considered for HDT-ASCT and post-transplant maintenance romidepsin:
  • PTCL
  • AITL
  • ALCL
  • EaTCL
Show all 16Show fewer
  • Hepatosplenic Gamma Delta T cell lymphoma
  • Adult T-cell leukemia/lymphoma
  • Primary cutaneous gamma/delta T-cell lymphoma
  • Extranodal NK/T-cell lymphoma, nasal type
  • Primary cutaneous anaplastic large cell lymphoma
  • Subcutaneous panniculitis-like T-cell lymphoma
  • Mycosis fungoides/sezary syndrome Stem cell collection: A minimum of 2 x 106 CD34+ cells must have been collected
  • Laboratory test results within these ranges:
  • Total bilirubin <= 1.5 x ULN
  • AST (SGOT) and ALT (SGPT) <= 3 x ULN

Who cannot join

  • Diagnosis: progressive disease at transplant work-up
  • Prior therapy: prior autologous or allogeneic transplant
  • Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
  • Inadequate performance status/organ function defined by DLCO < 50% (adjusted for hgb), cardiac function as defined below, KPS < 60%.
  • Pregnant or breast feeding. For males and females of child-producing potential, inability to use effective contraceptive methods during the study
  • Prior therapy with romidepsin
Show all 21Show fewer
  • Central nervous system or meningeal involvement
  • Any known cardiac abnormalities such as:
  • Congenital long QT syndrome
  • QTc interval ≥ 500 milliseconds
  • Myocardial infarction within 6 months of transplantation. Subjects with a history of myocardial infarction between 6 and 12 months prior to transplant who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
  • Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
  • Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix 1) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
  • An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix 2) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI
  • A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
  • Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
  • Uncontrolled hypertension, defined as blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
  • Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
  • Patients taking drugs leading to significant QT prolongation within the specified wash out period (See Appendix 3: Medications That May Cause QTc Prolongation).
  • Concomitant use of CYP3A4 inhibitors

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11065

  • Weill Cornell Medical Center

    New York, New York

  • Fred Hutchinson Cancer Research Center (Data Collection Only)

    Seattle, Washington, 98109

  • University of Washington (Data Collection Only)

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation.

Read the detailed description

The primary aim is to determine a preliminary estimate of the progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies.

Secondary aims include:

  • Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies.
  • Determine the toxicities associated with romidepsin following autologous transplantation
  • Determine the probability of OS at 2 years post transplant for all patients undergoing transplant
  • Characterize the effect of romidepsin on immune recovery post HDT-ASCT
  • OS and PFS 1 year after Romidespin completion

Patients who receive romidepsin after transplant will be evaluable for the primary endpoint, and will be counted towards the accrual total. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced. We will also accrue a second cohort of 8 patients who are transplanted in >CR/PR2 and for high risk histologies to be analyzed for secondary endpoints only. This cohort will not be part of the primary endpoint and will be analyzed for summary statistics only. Patients who receive romidepsin after transplant will be counted towards the accrual total for Cohort 2. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced.

Being tested
High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin
Medical subject headings
Lymphoma, T-Cell

What participants receive

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

  • High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with RomidepsinOther

    Also called Carmustine, VP-16 (etoposide, Vepesid®), Cytarabine (Ara-C), Melphalan (Alkeran)

Study groups in NCT01908777
Study groupRoleWhat they receive
high dose chemo w/asct + maintenance txtExperimentalHigh dose chemotherapy (Carmustine), VP-16 (etoposide, Vepesid®), Cytarabine (Ara-C), Melphalan (Alkeran)with autologous stem cell transplant followed by maintenance therapy with Romidepsin (Istodax)
Receives: Other: High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin

What is being measured

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

  1. The progression-free survival of patients

    The progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies.

    Measured: 2 Years

Secondary outcomes (5)

  1. Progression Free Survival for patients with high risk histologies

    Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies.

    Measured: 2 Years

  2. Toxicities

    Determine the toxicities associated with romidepsin following autologous transplantation. Toxicities will be graded on a scale of 0 to 5 as described by the NCI- Common Terminology for Adverse Events (CTCAE), version 4.0

    Measured: 2 years

  3. Probability of OS at 2 years post transplant

    Determine the probability of OS at 2 years post transplant for all patients undergoing transplant

    Measured: 2 year post transplant

  4. OS 1 year after Romidespin completion

    OS 1 year after Romidespin completion

    Measured: 1 year

  5. PFS 1 year after Romidespin completion

    PFS 1 year after Romidespin completion

    Measured: 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 posted26 Jul 2013 (estimated)
  2. Study start16 Jul 2013
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908777
Sponsor's protocol ID
13-020
Status last verified
Oct 2025
First submitted
17 Jul 2013
Last updated
9 Oct 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Khan N, Dahi PB, Khimani F, Shustov AR, Shadman M, Ruan J, Moskowitz AJ, Zelenetz AD, Noy A, Straus DJ, Drullinsky P, Hamilton A, Kumar A, Sauter CS, Shah GL, Matasar MJ, Drill E, Davey T, Hancock H, Ganesan N, Galasso N, van Beisen K, Giralt S, Horwitz SM. Maintenance therapy with romidepsin after autologous stem-cell transplant for peripheral T-cell lymphoma. Blood Adv. 2025 Sep 23;9(18):4687-4692. doi: 10.1182/bloodadvances.2024014263.

    PubMed 40179392

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin in people with T Cell Non-Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 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 16 inclusion and 21 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 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The progression-free survival of patients (time frame: 2 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 NCT01908777, 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 9 Oct 2025.

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