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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2017-10-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Non-Hodgkin's Lymphoma (NHL)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 )

Group Type EXPERIMENTAL

R-CHOEP 14 with 12x Rituximab

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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12 x Rituximab with 8 cycles of standard CHOEP-14

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No