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

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

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin's Lymphoma (NHL)

Treatments: Drug: R-CHOEP 14 with 12x Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00129090

DSHNHL 2002-1

Details and patient eligibility

About

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)

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

R-CHOEP14 with 12x Rituximab

Experimental group

Description:

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 )

Treatment:

Drug: R-CHOEP 14 with 12x Rituximab