Study of Gelonin Purging of Autologous Stem Cells for Transplantation
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|ClinicalTrials.gov Identifier: NCT00043810|
Recruitment Status : Terminated
First Posted : August 15, 2002
Last Update Posted : July 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Myelodysplastic Syndrome||Procedure: Gelonin Drug: Busulfan Drug: Fludarabine||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
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).
- Optimal Dose Gelonin [ Time Frame: 28 days post transplant ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|