Spots Global Cancer Trial Database for CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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