Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.
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|ClinicalTrials.gov Identifier: NCT00355199|
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma||Drug: Rituximab-HDS Drug: Rituximab-CHOP||Phase 3|
Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission (which can be considered cured) and patients that relapse. This last group of subjects have only 25%-33% chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC.
Therefore in order to achieve an improvement of the overall survival in patient with DLBCL, it is necessary to increase the number of complete remission after first line therapy.
The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkin's Lymphomas|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
Other Name: Rituximab supplemented high-dose sequential chemotherapy.
Active Comparator: R-CHOP
Other Name: Rituximab/Cyclophosph/doxorubic/vincrist/prednis
- Event Free Survival [ Time Frame: 36 months from end of therapy ]EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit
- Complete Remission [ Time Frame: Through therapy completion an average of 8 months ]Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007
- Disease Free Survival [ Time Frame: 36 months from end of therapy ]DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit
- Overall Survival [ Time Frame: 36 months from end of therapy ]OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit
- Toxicity [ Time Frame: Through therapy completion an average of 8 months ]Percentage of participants with at least one reported episode of CTC grade III or IV toxic events
- Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14 [ Time Frame: Through completion of salvage therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355199
|Clinica di Ematologia - Nuovo Ospedale Torrette|
|U.O. Ematologia - Ospedali Riuniti di Bergamo|
|Divisione di Ematologia - Ospedale Centrale di Bolzano|
|CTMO - Ematologia - Ospedale "R. Binaghi"|
|Divisione di Ematologia - Ospedale Ferrarotto|
|S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle|
|Divisione Ematologia - Istituto S. Raffaele|
|Oncologia Medica - Istituto Nazionale dei Tumori|
|U.O. Ematologia - Istituto Nazionale dei Tumori|
|Divisione di Ematologia - Azienda Ospedaliera|
|Ematologia - Azienda Ospedaliera V. Cervello|
|Ematologia Clinica - Ospedale Civile di Pescara|
|Ematologia e TMO - Ospedale S. Camillo|
|Divisione Universitaria di Ematologia - Azienda Ospedaliera S. Giovanni Battista (Molinette)|
|Dipartimento di Medicina Clinica e Sperimentale - Università di Verona|
|Divisione di Ematologia - Presidio Ospedaliero S. Bortolo|
|Study Chair:||Sergio Cortelazzo, MD||Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy|