High Dose CHOP in Lymphoma
This study has been completed.
Sponsor:
Rambam Health Care Campus
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192764
First received: September 13, 2005
Last updated: September 21, 2010
Last verified: September 2010
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | September 21, 2010 | ||||
| Start Date ICMJE | December 1996 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Failure-free survival | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00192764 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | High Dose CHOP in Lymphoma | ||||
| Official Title ICMJE | Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma | ||||
| Brief Summary | The study hypothesis is that intensification of CHOP by dose escalation of the most active drugs in the combination will improve treatment outcome. Patients with diffuse large-cell lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2 which is 4 times the atandard one. Only 4 cycles are given. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Non-Hodgkin's Lymphoma | ||||
| Intervention ICMJE | Drug: high-dose cyclophosphamide | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | 45 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| 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 | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00192764 | ||||
| Other Study ID Numbers ICMJE | RonHDCHOP.CTIL | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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