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| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 14, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | July 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00043810 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study of Gelonin Purging of Autologous Stem Cells for Transplantation |
| Official Title ICMJE | Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission |
| Brief Summary | Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes |
| Detailed Description | |
| Study Phase | Phase I, Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Procedure: gelonin for purging autologous stem cells |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | 24 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00043810 |
| Responsible Party | |
| Study ID Numbers ICMJE | ID02-060 |
| Study Sponsor ICMJE | M.D. Anderson Cancer Center |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | M.D. Anderson Cancer Center |
| Verification Date | June 2005 |
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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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