Clinical trial NCT01746173: CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
Official title: A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: T-cell Non-Hodgkin Lymphoma
Keywords: T Cell lymphoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2012-12-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 24-month Progression-Free Survival Rate
timeFrame: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
Secondary outcomes:
measure: Induction Response
timeFrame: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Philippe Armand, MD
role: PRINCIPAL_INVESTIGATOR
References: