| January 4, 2008 |
| July 30, 2009 |
| December 2007 |
| December 2012 (final data collection date for primary outcome measure) |
| To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. [ Time Frame: thru 6 months after transplant ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00593554 on ClinicalTrials.gov Archive Site |
- Describe regimen-related toxicity [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: Yes ]
- Describe the time to engraftment of neutrophils and platelets following haplotype-mismatched CD34 selected cells [ Time Frame: baseline through end of study ] [ Designated as safety issue: No ]
- Assess the risks of acute and chronic GvHD following infusion of highly purified CD34 cells [ Time Frame: baseline through end of study ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies |
| A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplasia
- Chronic Myeloid Leukemia
|
- Radiation: Total Body Irradiation
- Drug: Thiotepa
- Drug: Fludarabine
- Biological: Rabbit ATG
- Drug: Palifermin
|
- Active Comparator: Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
- Experimental: Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
|
| |
| |
| Recruiting |
| 46 |
|
| December 2012 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria
- CR 1 with poor risk features
- CR 2, or higher order CR
Acute lymphoblastic leukemia (ALL) with one of the following criteria
- CR 1 with poor risk features
- CR 2, or higher order CR
- Myelodysplasia, RAEB I
- Donor has been identified
- Age ≤ 65 years.
- Performance Status 0-1.
Exclusion Criteria:
- Patients relapsing <6 months after autologous SCT are not eligible.
- Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
- Non-pregnant and non-nursing
|
| Both |
| 18 Years to 65 Years |
| No |
|
|
| United States |
| |
| NCT00593554 |
| Sherif Farag, MD, PhD/ Principal Investigator, Indiana University School of Medicine |
| 0704-19 IUCRO-0184 |
| Indiana University |
|
| Principal Investigator: |
Sherif Farag, MD/PhD |
Indiana University School of Medicine |
|
|
| Indiana University |
| July 2009 |
