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A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT

NCT00791947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2011-09-08

No results posted yet for this study

Summary

This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.

The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.

Conditions

  • Peripheral T-Cell Lymphoma

Interventions

DRUG

CHOEP + G-CSF followed by BEAM

CHOEP: Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5 BEAM: Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6

Sponsors & Collaborators

  • Nordic Lymphoma Group

    collaborator NETWORK

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Francesco d'Amore, MD · Nordic Lymphoma Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2008-08-31
Completion
2010-08-31

Countries

  • Denmark
  • Finland
  • Norway

Study Locations

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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 NCT00791947 on ClinicalTrials.gov