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

Phase 3

Completed

• Conditions: Non-Hodgkin's Lymphoma (NHL)
• Interventions: Drug: R-CHOEP 14 with 12x Rituximab

• Registration Number: NCT00129090
• Lead Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group

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)

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-08-10
• Study First Submitted QC: 2005-08-10
• Study First Posted: 2005-08-11
• Primary Completion: 2014-10
• Study Completion: 2017-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-CHOEP14 with 12x Rituximab	R-CHOEP 14 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 )

Primary Outcome Measures

Name	Time	Method
time to treatment failure	3 years after study inclusion	At 3 year follow up rate of treatments and time to treatment failure will be determined

Trial Locations

Locations (1)

AK St. Georg; 🇩🇪 Hamburg, Germany