Study of Gelonin Purging of Autologous Stem Cells for Transplantation
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
Acute Myelogenous Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission|
- Optimal Dose Gelonin [ Time Frame: 28 days post transplant ] [ Designated as safety issue: Yes ]Dose-finding success, defined as patient alive and engrafted at day 28 post transplant, represented as number of patient successes with 3 differing doses (5, 10, or 15 nanomolar (nm) gelonin-antiCD33 purged autologous stem cells after a high dose fludarabine/busulfan conditioning regimen).
|Study Start Date:||July 2002|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Experimental: Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan
Gelonin-AntiCD33 purging, 3 purging concentrations (fixed dose of 5 x 10^6 CD34+ cells/kg to be infused) with 3 dose levels of 1 nanomolar, 5.0 nanomolar and 10.0 nanomolar.
Other Name: HuM195-Gelonin conjugateDrug: Busulfan
130 mg/m2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -6 to -3).
Other Names:Drug: Fludarabine
40 mg/m2 in 100 ml of saline over one (1) hour on each of four (4) consecutive days (days - 6 to -3).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00043810
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sergio A. Giralt, MD||UT MD Anderson Cancer Center|