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| Sponsored by: |
Indiana University |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00593554 |
Purpose
The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
| Condition | Intervention | Phase |
|
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia |
Radiation: Total Body Irradiation Drug: Thiotepa Drug: Fludarabine Biological: Rabbit ATG Drug: Palifermin |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| ChemIDplus related topics: | Thiotepa Fludarabine Fludarabine monophosphate Palifermin Fibroblast growth factor 7 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies |
| Estimated Enrollment: | 46 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
|
Radiation: Total Body Irradiation
8 Gy on Day -9
Drug: Thiotepa
5 mg/kg/d on Day -8 to -7
Drug: Fludarabine
40 mg/m2/d on Day -6 to -3
Biological: Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
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2: Experimental
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
|
Radiation: Total Body Irradiation
8 Gy on Day -9
Drug: Thiotepa
5 mg/kg/d on Day -8 to -7
Drug: Fludarabine
40 mg/m2/d on Day -6 to -3
Biological: Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
Drug: Palifermin
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
|
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria
Acute lymphoblastic leukemia (ALL) with one of the following criteria
Exclusion Criteria:
Contacts and Locations| Contact: Lisa Wood, RN | 317-274-1781 | llwood@iupui.edu |
| Contact: Sherif Farag, MD | 317-274-0843 | ssfarag@iupui.edu |
| United States, Indiana | |||||
| Indiana University Cancer Center | Recruiting | ||||
| Indianapolis, Indiana, United States, 46202 | |||||
| Contact: Lisa Wood, RN 317-274-1781 llwood@iupui.edu | |||||
| Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu | |||||
| Indiana University |
| Principal Investigator: | Sherif Farag, MD/PhD | Indiana University School of Medicine |
More Information
IU Simon Cancer Center "Find a Clinical Trial" 
  |
| Responsible Party: | Indiana University School of Medicine ( Sherif Farag, MD, PhD/ Principal Investigator ) |
| Study ID Numbers: | 0704-19 IUCRO-0184 |
| First Received: | January 4, 2008 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00593554 |
| Health Authority: | United States: Food and Drug Administration |
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