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

Non-Hodgkin's Lymphoma (NHL) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129090
• Other study ID #: DSHNHL 2002-1
• Status: Completed
• Phase: Phase 3
• Start date: March 2003
• Est. completion date: October 2017

Study information

• Verified date: May 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma (NHL)

Intervention

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)

Locations

Country	Name	City	State
Germany	AK St. Georg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
German High-Grade Non-Hodgkin's Lymphoma Study Group	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to treatment failure	At 3 year follow up rate of treatments and time to treatment failure will be determined	3 years after study inclusion