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

NCT01746173 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-01-30

Study results available
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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.

Conditions

  • T-cell Non-Hodgkin Lymphoma

Interventions

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Etoposide

DRUG

Prednisone

DRUG

Filgrastim

DRUG

Plerixafor

PROCEDURE

Stem Cell Collection

DRUG

Palifermin

DRUG

Gemcitabine

DRUG

Busulfan

DRUG

Melphalan

PROCEDURE

Stem Cell Transplant

Sponsors & Collaborators

Principal Investigators

  • Philippe Armand, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746173 on ClinicalTrials.gov