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Clinical Trial 18664

Cancer Type: Malignant Hematology
Interventions:Alkeran (Melphalan); Carmustine; Cytarabine (Cytosine Arabinoside); FK228 (Romidepsin); Melphalan; Romidepsin; etoposide

Study Type: Treatment
Phase of Study: Phase II

  • Farhad Khimani

Call 813-745-6100
or 1-800-679-0775

Study Title

A Phase 2, Multi-Center Study of High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin for the Treatment of T cell Non-Hodgkin's Lymphoma


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.


Primary aim is to determine a preliminary estimate of the progression-free survival (PFS) of patients with T cell Non-Hodgkin's Lymphoma (T NHL) who receive maintenance Romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies. Secondary: Determine PFS at 2 years for patients transplanted in >/= CR/PR2 or for patients with high risk histologies. Determine the toxicities associated with Romidepsin in following autologous transplantation. Determine the probability of Overall Survival (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 Romidepsin completion.

Inclusion Criteria

  • Age: Patients over age 16 who are deemed eligible for transplant by their treating physician.
  • Disease status: Complete Response (CR) or Partial Response (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 Memorial Sloan Kettering (MSK) or locally for participating sites, in order to be considered for HDT-ASCT and post-transplant maintenance romidepsin: Peripheral T-cell lymphoma (PTCL); Angioimmunoblastic T cell lymphoma (AITL); Anaplastic T cell lymphoma (ALCL); Enteropathy-type T cell lymphoma (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 10^6 CD34+ cells must have been collected.
  • Laboratory test results within these ranges: Total bilirubin less than or equal to 1.5 x Upper Limit of Normal (ULN); AST (SGOT) and ALT (SGPT) less than or equal to 3 x ULN.

  • Exclusion Criteria

  • 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 carbon monoxide diffusing capacity (DLCO) less than 50% (adjusted for hgb), Karnofsky Performance Status (KPS) less than 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 (CNS) or meningeal involvement
  • Any known cardiac abnormalities