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| Sponsors and Collaborators: |
German High-Grade Non-Hodgkin's Lymphoma Study Group Deutsche Krebshilfe e.V., Bonn (Germany) |
|---|---|
| Information provided by: | German High-Grade Non-Hodgkin's Lymphoma Study Group |
| ClinicalTrials.gov Identifier: | NCT00129090 |
Purpose
Comparison of aggressive conventional therapy with repetitive high-dose therapy plus rituximab. Hypothesis: better overall survival and/or progression-free survival in HDT+R.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: CHOEP + Rituximab Drug: Mega-CHOEP + Rituximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 396 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1B: Active Comparator
8 x CHOEP-14 + 6 x R
|
Drug: CHOEP + Rituximab
8 x CHOEP-14 + 6 x Rituximab
|
|
2B: Experimental
4 x R-MegaCHOEP
|
Drug: Mega-CHOEP + Rituximab
4 x R-Mega-CHOEP
|
This study compares aggressive conventional therapy (8 courses of rituximab plus CHOEP given every 2 weeks) with repetitive high-dose therapy (Mega-CHOEP) supplemented with rituximab. The study question is whether overall survival or progression-free survival is better with high-dose therapy than with conventional treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Norbert Schmitz, Prof. | +49 40 181885 ext 2005 | norbert.schmitz@ak-stgeorg.lbk-hh.de |
| Germany | |
| AK St. Georg | Recruiting |
| Hamburg, Germany, 20099 | |
| Contact: Norbert Schmitz, Prof. +49 40 181885 ext 2005 norbert.schmitz@ak-stgeorg.lbk-hh.de | |
| Principal Investigator: Schmitz Norbert, Prof. | |
| Principal Investigator: | Norbert Schmitz, Prof. | German High-Grade Non-Hodgkin's Lymphoma Study Group |
More Information
| Responsible Party: | ( Deutsche Studiengruppe Hochmaligne Non-Hodgkin-Lymphome (DSHNHL) ) |
| Study ID Numbers: | DSHNHL 2002-1 |
| Study First Received: | August 10, 2005 |
| Last Updated: | May 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00129090 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Aggression Lymphoma, Non-Hodgkin Lymphoma |
|
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |
