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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00129090

Recruitment Status : Completed

First Posted : August 11, 2005

Last Update Posted : May 25, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Deutsche Krebshilfe e.V., Bonn (Germany)

Information provided by (Responsible Party):

Universität des Saarlandes ( German High-Grade Non-Hodgkin's Lymphoma Study Group )

Study Description

Brief Summary:

According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma (NHL)	Drug: R-CHOEP 14 with 12x Rituximab	Phase 3

Detailed Description:

This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.

A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.

As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	450 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	March 2003
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: R-CHOEP14 with 12x Rituximab 8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 )	Drug: R-CHOEP 14 with 12x Rituximab after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle) Other Name: 12 x Rituximab with 8 cycles of standard CHOEP-14

Outcome Measures

Primary Outcome Measures :

time to treatment failure [ Time Frame: 3 years after study inclusion ]
At 3 year follow up rate of treatments and time to treatment failure will be determined

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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: Eastern Cooperative Oncology Group (ECOG) 0-3
Patient's written informed consent
Aggressive non-Hodgkin's lymphoma with CD20+ histology

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129090

Locations

Layout table for location information

Germany
AK St. Georg
Hamburg, Germany, 20099

Sponsors and Collaborators

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

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

Layout table for investigator information

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frontzek F, Ziepert M, Nickelsen M, Altmann B, Glass B, Haenel M, Truemper L, Held G, Bentz M, Borchmann P, Dreyling M, Viardot A, Kroschinsky FP, Metzner B, Staiger AM, Horn H, Ott G, Rosenwald A, Loeffler M, Lenz G, Schmitz N. Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial. Lancet Haematol. 2021 Apr;8(4):e267-e277. doi: 10.1016/S2352-3026(21)00022-3. Epub 2021 Mar 2.

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.

Layout table for additonal information

Responsible Party:	German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier:	NCT00129090
Other Study ID Numbers:	DSHNHL 2002-1
First Posted:	August 11, 2005 Key Record Dates
Last Update Posted:	May 25, 2023
Last Verified:	May 2023

Additional relevant MeSH terms:

Layout table for MeSH terms

Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders	Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

To Top