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

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Massachusetts General Hospital
• Treatments: Busulfan; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Gemcitabine; JM 3100; Lenograstim; Liposomal doxorubicin; Melphalan; Plerixafor; Prednisone; Vincristine

Criteria

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