Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma - Full Text View

Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified by German High-Grade Non-Hodgkin's Lymphoma Study Group, May 2008

Sponsors and Collaborators:	German High-Grade Non-Hodgkin's Lymphoma Study Group Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:	German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier:	NCT00129090

Purpose

Comparison of aggressive conventional therapy with repetitive high-dose therapy plus rituximab. Hypothesis: better overall survival and/or progression-free survival in HDT+R.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: CHOEP + Rituximab Drug: Mega-CHOEP + Rituximab	Phase III

MedlinePlus related topics:

Lymphoma

ChemIDplus related topics:

Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by German High-Grade Non-Hodgkin's Lymphoma Study Group:

Primary Outcome Measures:

time to treatment failure

Estimated Enrollment:	396
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1B: Active Comparator 8 x CHOEP-14 + 6 x R	Drug: CHOEP + Rituximab 8 x CHOEP-14 + 6 x Rituximab
2B: Experimental 4 x R-MegaCHOEP	Drug: Mega-CHOEP + Rituximab 4 x R-Mega-CHOEP

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129090

Contacts


Contact: Norbert Schmitz, Prof.	+49 40 181885 ext 2005	norbert.schmitz@ak-stgeorg.lbk-hh.de

Locations


Germany
	AK St. Georg	Recruiting
	Hamburg, Germany, 20099
	Contact: Norbert Schmitz, Prof. +49 40 181885 ext 2005 norbert.schmitz@ak-stgeorg.lbk-hh.de
	Principal Investigator: Schmitz Norbert, Prof.

Sponsors and Collaborators

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

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators


Principal Investigator:	Norbert Schmitz, Prof.	German High-Grade Non-Hodgkin's Lymphoma Study Group

More Information

Responsible Party:	( Deutsche Studiengruppe Hochmaligne Non-Hodgkin-Lymphome (DSHNHL) )
Study ID Numbers:	DSHNHL 2002-1
First Received:	August 10, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00129090
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Rituximab

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Aggression

Lymphoma, Non-Hodgkin

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008