NCT01746173

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

A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• T-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide
DRUG	Doxorubicin
DRUG	Vincristine
DRUG	Etoposide
DRUG	Prednisone
DRUG	Filgrastim
DRUG	Plerixafor
PROCEDURE	Stem Cell Collection
DRUG	Palifermin
DRUG	Gemcitabine
DRUG	Busulfan
DRUG	Melphalan
PROCEDURE	Stem Cell Transplant

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-12-10
• Last updated: 2023-01-30
• Results posted: 2017-01-11

Locations

2 sites across 1 country: United States