drugset / Trial / NCT01746173
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
Phase 2
Terminated
5 enrolled
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center · collabMassachusetts General Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-07
- Primary completion
- 2014-10
- Completion
- 2014-10
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual and futility”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Busulfan | Small molecule | 105 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 2700 mg/m2 | — |
| Background | Melphalan | Small molecule | 60 mg/m2 | — |
| Background | Palifermin | Protein / enzyme biologic | — | — |
| Background | Plerixafor | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Vincristine | Small molecule | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |