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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00129090
Other study ID # DSHNHL 2002-1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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