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

T-cell Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01746173
• Other study ID #: 12-388
• Status: Terminated
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T-cell Non-Hodgkin Lymphoma

Intervention

Drug:
• Cyclophosphamide

• Doxorubicin

• Vincristine

• Etoposide

• Prednisone

• Filgrastim

• Plerixafor

Procedure:
• Stem Cell Collection

Drug:
• Palifermin

• Gemcitabine

• Busulfan

• Melphalan

Procedure:
• Stem Cell Transplant

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-month Progression-Free Survival Rate	24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).	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	Induction Response	Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.	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).