Non Hodgkin Lymphoma Clinical Trial
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
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.
Full 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
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
How clear is this clinincal trial information?