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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by German High-Grade Non-Hodgkin's Lymphoma Study Group.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Deutsche Krebshilfe e.V., Bonn (Germany)

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00129090

First received: August 10, 2005

Last updated: May 5, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2005

Last Updated Date

May 5, 2008

Start Date ^ICMJE

March 2003

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

time to treatment failure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00129090 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: CHOEP + Rituximab
8 x CHOEP-14 + 6 x Rituximab
Drug: Mega-CHOEP + Rituximab
4 x R-Mega-CHOEP

Study Arm (s)

Active Comparator: 1B
8 x CHOEP-14 + 6 x R

Intervention: Drug: CHOEP + Rituximab
Experimental: 2B
4 x R-MegaCHOEP

Intervention: Drug: Mega-CHOEP + Rituximab

Publications *

Schmitz N, Nickelsen M, Ziepert M, Haenel M, Borchmann P, Schmidt C, Viardot A, Bentz M, Peter N, Ehninger G, Doelken G, Ruebe C, Truemper L, Rosenwald A, Pfreundschuh M, Loeffler M, Glass B; German High-Grade Lymphoma Study Group (DSHNHL). Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1). Lancet Oncol. 2012 Dec;13(12):1250-9. doi: 10.1016/S1470-2045(12)70481-3. Epub 2012 Nov 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

396

Estimated Completion Date

March 2011

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Norbert Schmitz, Prof.

+49 40 181885 ext 2005

norbert.schmitz@ak-stgeorg.lbk-hh.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00129090

Other Study ID Numbers ^ICMJE

DSHNHL 2002-1

Has Data Monitoring Committee

Not Provided

Responsible Party

Deutsche Studiengruppe Hochmaligne Non-Hodgkin-Lymphome (DSHNHL)

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators ^ICMJE

Principal Investigator:

Norbert Schmitz, Prof.

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

Information Provided By

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

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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