Clinical trial NCT01746173
Conditions: T-cell Non-Hodgkin Lymphoma
Keywords: T Cell lymphoma
Sponsor: Dana-Farber Cancer Institute
Start date: 2013-07-01; Completion date: 2014-10-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.

Detailed description:
Objectives:

Primary

* To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy

Secondary

* To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT
* To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM)
* To estimate the toxicity (grade 3 and above)
* To estimate the rate of successful stem cell mobilization after CHOEP in responding patients
* To estimate the proportion of patients who can successfully complete the entire treatment regimen
* To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
* To determine whether tumor DNA can be detected in peripheral blood of patients before therapy
* To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT

Arms: arm 1: Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
Interventions: intervention 1: Cyclophosphamide intervention 2: Doxorubicin intervention 3: Vincristine intervention 4: Etoposide intervention 5: Prednisone intervention 6: Filgrastim intervention 7: Plerixafor intervention 8: Stem Cell Collection intervention 9: Palifermin intervention 10: Gemcitabine intervention 11: Busulfan intervention 12: Melphalan intervention 13: Stem Cell Transplant
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None

Protocol documents: