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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00043810 |
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
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Procedure: gelonin for purging autologous stem cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | ID02-060 |
Study First Received: | August 14, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00043810 |
Health Authority: | United States: Food and Drug Administration |
AML MDS Gelonin |
Purging Transplant Peripheral Stem Cell |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid |
Leukemia, Myeloid, Acute Leukemia Signs and Symptoms Preleukemia GEL protein, Gelonium multiflorum Bone Marrow Diseases Acute myelocytic leukemia |
Protein Synthesis Inhibitors Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |