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

NCT ID: NCT01746173

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

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

Conditions

T-cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHOEP + High Dose Therapy + Auto SCT

Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Filgrastim

Intervention Type: DRUG

Plerixafor

Intervention Type: DRUG

Stem Cell Collection

Intervention Type: PROCEDURE

Palifermin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Busulfan

Intervention Type: DRUG

Melphalan

Intervention Type: DRUG

Stem Cell Transplant

Intervention Type: PROCEDURE

Interventions

Cyclophosphamide

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Filgrastim

Intervention Type: DRUG

Plerixafor

Intervention Type: DRUG

Stem Cell Collection

Intervention Type: PROCEDURE

Palifermin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Busulfan

Intervention Type: DRUG

Melphalan

Intervention Type: DRUG

Stem Cell Transplant

Intervention Type: PROCEDURE

Other Intervention Names

cytoxan; adriamycin; oncovin; Etopophos; Toposar; Etoposide phosphate; neupogen; G-CSF; mozobil; Leukapheresis; KGF; kepivance; gemzar; busulfex; Stem Cell Infusion

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Philippe Armand, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Armand, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

12-388

Identifier Type: -

Identifier Source: org_study_id