Efficacy of 6 courses CHOP plus Rituximab followed by myeloablative radiochemotherapy and autologous stem cell transplantation versus alternating courses of 3x CHOP and 3x DHAP plus Rituximab followed by a high dose ARA-C containing myeloablative regimen and autologous stem cell transplantation
Kategorie: Indolente Lymphome/MCL
Clinical Trials Register (clinicaltrials.gov)
standard arm: 6 cycles CHOP plus Rituximab followed by myeloablative radiochemotherapy (12 Gray TBI, cyclo 2x 60 mg/m2) and autologous stem cell transplantation
experimental arm: alternating cycles of 3x CHOP and 3x DHAP plus Rituximab followed by a high dose ARA-C containing myeloablative radiochemotherapy (10 Gray TBI, Ara-C, Melphalan) and autologous stem cell transplantation
Abgeschlossen
Mantelzell- Lymphom
497
Phase III
The study addresses the impact of CHOP and high dose ARA-C plus anti-CD20 (Rituximab) during induction followed by a high dose ARA-C containing myeloablative radio-chemotherapy regimen and autologous blood stem cell transplantation on time to treatment failure, complete response rate, progression-free and overall survival in comparison to CHOP plus Rituximab followed by the standard myeloablative radio-chemotherapy and PBSCT.
The current study is designed for previously untreated patients at 18 to 65 years of age with advanced stage mantle cell lymphomas.
time to treatment failure
complete remission rate (CR-rate)
overall response rate (OR-rate)
progression-free survival (PFS)
overall survival (OS)
toxicity
minimal residual disease (MRD)
Ja
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