CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma

• Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To estimate the response rate (completed remission [CR] and partial remission [PR]) after CHOEP x 6 and after Gem/Bu/Mel ASCT
• Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Overall survival of patients at 2 years
• Grade 3 and above toxicity related to study regimen [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  To estimate the toxicity (grade 3 and above) with this regimen using CTCAE v4.0. All grade 3 and above adverse events, and all serious adverse events will be recorded. This will be reported as number of events and as number of patients with events for all events of interest.
• Stem cell mobilization rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the rate of successful stem cell mobilization after CHOEP in responding patients.
• Proportion of patients who successfully complete regimen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To estimate the proportion of patients who can successfully complete the entire treatment regimen
• Engraftment time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
• Relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To estimate the cumulative incidence of relapse at 24 months
• Treatment-related mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  To estimate the cumulative incidence of treatment-related mortality at 24 months

This is a phase II study of CHOEP induction chemotherapy followed by autologous stem cell transplant using gemcitabine/busulfan/melphalan conditioning in patients with newly diagnosed systemic T-cell non-Hodgkin lymphoma.

This is a phase II study of CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone)induction chemotherapy followed by autologous stem cell transplant using gemcitabine/busulfan/melphalan conditioning in patients with newly diagnosed systemic T-cell non-Hodgkin lymphoma. The study treatment comprises 6 cycles of CHOEP, followed (for responding patients) by stem cell mobilization and harvesting (using neupogen +/- plerixafor) followed by high dose therapy and autologous stem cell transplantation,

• Drug: Cyclophosphamide
  Intravenous, on Day 1, 3 or 6 cycles
  Other Name: cytoxan
• Drug: Doxorubicin
  Intravenously, on Day 1, 3 or 6 cycles
  Other Name: adriamycin
• Drug: Vincristine
  Intravenously, on Day 1, 3 or 6 cycles
  Other Name: oncovin
• Drug: Etoposide
  Intravenously or orally, Day 1,2 and 3, 3 or 6 cycles
• Drug: Prednisone
  Taken orally, days 1-5
• Drug: Filgrastim
  Subcutaneous daily injection for 5-7 days
  Other Names:

  • neupogen
  • G-CSF
• Drug: Plerixafor
  daily subcutaneous injections for 0-2 days
  Other Name: mozobil
• Procedure: Stem Cell Collection
  Leukapheresis used to collect stem cells from peripheral blood
  Other Name: Leukapheresis
• Drug: Palifermin
  Daily intravenous infusion
  Other Names:

  • KGF
  • kepivance
• Drug: Gemcitabine
  intravenous infusion for 2 days
  Other Name: gemzaar
• Drug: Busulfan
  intravenous infusion for 4 days
  Other Name: busulfex
• Drug: Melphalan
  intravenous infusion for 2 days
• Procedure: Stem Cell Transplant
  Reinfusion of stored peripheral blood stem cells
  Other Name: Stem Cell Infusion

Inclusion Criteria:

• Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital
• Measurable disease
• Candidate for Autologous Stem Cell Transplant

Exclusion Criteria:

• Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP)
• Pregnant or breastfeeding
• Alk-positive ACL
• Significant neuropathy precluding vincristine administration
• Known hypersensitivity to any of the agents used in the treatment
• Uncontrolled intercurrent illness
• Receiving other investigational agents
• History of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin
• HIV positive on anti-retroviral therapy

• Massachusetts General Hospital
• Beth Israel Deaconess Medical Center