HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
This study has been completed.
Sponsor:
Gruppo Italiano Studio Linfomi
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT00866203
First received: March 13, 2007
Last updated: March 19, 2009
Last verified: March 2009
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First Received Date ICMJE | March 13, 2007 | ||||||||||||||||||||
Last Updated Date | March 19, 2009 | ||||||||||||||||||||
Start Date ICMJE | October 2000 | ||||||||||||||||||||
Primary Completion Date | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00866203 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
feasibility and toxicity [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy | ||||||||||||||||||||
Official Title ICMJE | A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy | ||||||||||||||||||||
Brief Summary | The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program. |
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Detailed Description | |||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase | Phase 3 | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | High-Grade Lymphomas | ||||||||||||||||||||
Intervention ICMJE | Drug: HDS vs ProMECE/CytaBOM | ||||||||||||||||||||
Study Arm (s) |
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Publications * | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||
Enrollment ICMJE | 441 | ||||||||||||||||||||
Completion Date | April 2008 | ||||||||||||||||||||
Primary Completion Date | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||||||
Ages | 18 Years to 65 Years | ||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Location Countries ICMJE | Italy | ||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT00866203 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | LA05 | ||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||
Responsible Party | sponsor, Gruppo Italiano Studio Linfomi | ||||||||||||||||||||
Study Sponsor ICMJE | Gruppo Italiano Studio Linfomi | ||||||||||||||||||||
Collaborators ICMJE | |||||||||||||||||||||
Investigators ICMJE |
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Information Provided By | Gruppo Italiano Studio Linfomi | ||||||||||||||||||||
Verification Date | March 2009 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |