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A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-Dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-Dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL


This study compares aggressive conventional therapy (8 courses of rituximab plus CHOEP given
every 2 weeks) with repetitive high-dose therapy (Mega-CHOEP) supplemented with rituximab.
The study question is whether overall survival or progression-free survival is better with
high-dose therapy than with conventional treatment.


Inclusion Criteria:



- 18-60 years of age

- Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)

- Performance status: ECOG 0-3

- Patient's written informed consent

- Aggressive non-Hodgkin's lymphoma

Exclusion Criteria:

- Already initiated lymphoma therapy

- Serious accompanying disorder or impaired organ function

- Bone marrow involvement > 25%

- Known hypersensibility to the medications to be used

- Known HIV-positivity

- Active hepatitis infection

- Suspicion that patient compliance will be poor

- Simultaneous participation in other trials

- Prior chemo- or radiotherapy for previous disorder

- Other concomitant tumour disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to treatment failure

Principal Investigator

Norbert Schmitz, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

German High-Grade Non-Hodgkin's Lymphoma Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DSHNHL 2002-1

NCT ID:

NCT00129090

Start Date:

March 2003

Completion Date:

March 2011

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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