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

NCT01908777 | Completed Phase 2 DMC

• 1 other identifier: 13-020
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

T Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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.

  2 Years

Secondary Outcomes (5)

• Progression Free Survival for patients with high risk histologies

  2 Years

• Toxicities

  2 years

• Probability of OS at 2 years post transplant

  2 year post transplant

• OS 1 year after Romidespin completion

  1 year

• PFS 1 year after Romidespin completion

  1 year

Study Arms (1)

high dose chemo w/asct + maintenance txt

EXPERIMENTAL

High dose chemotherapy (Carmustine), VP-16 (etoposide, Vepesid®), Cytarabine (Ara-C), Melphalan (Alkeran)with autologous stem cell transplant followed by maintenance therapy with Romidepsin (Istodax)

Other: High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin

Interventions

High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin OTHER

Also known as: Carmustine, VP-16 (etoposide, Vepesid®), Cytarabine (Ara-C), Melphalan (Alkeran), Romidepsin (Istodax)

high dose chemo w/asct + maintenance txt

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Washington: collaborator
• Weill Medical College of Cornell University: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (10)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 11065, United States

Location

Weill Cornell Medical Center

New York, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Fred Hutchinson Cancer Research Center (Data Collection Only)

Seattle, Washington, 98109, United States

Location

University of Washington (Data Collection Only)

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 40179392 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Drug Therapy; romidepsin; Carmustine; Etoposide; Cytarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Horowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 26, 2013
• Study Start: July 16, 2013
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (10)