| January 8, 2008 |
| August 26, 2008 |
| March 2007 |
| January 2020 (final data collection date for primary outcome measure) |
| Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital. [ Time Frame: To study end ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00619879 on ClinicalTrials.gov Archive Site |
- Evaluate the effectiveness of graft versus host disease prevention with a combination of anti-thymocyte globulin, continuous infusion cyclosporine, and short course methotrexate for transplants. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
- Determine the toxicity of a single conditioning regimen consisting of total body irradiation, etoposide, and cyclophosphamide for patients with transplant eligible lymphoid malignant conditions. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
- Determine the toxicity of a single conditioning regimen consisting of busulfan and cyclophosphamide for patients with transplant eligible myeloid malignant conditions. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies |
| Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies |
The purpose of this study is to show that myeloablative hematopoietic progenitor cell transplantation (HPCT) continues to offer acceptable disease-free survival for select patients requiring HPCT. |
Myeloablative hematopoietic progenitor cell transplantation (HPCT) remains the standard of care for patients requiring HPCT. The purpose of this study is to evaluate the morbidity and mortality of myeloablative HPCT at Children's Memorial Hospital. It will also look to determine the toxicity of a single conditioning regimen consisting of either total body irradiation, etoposide, and cyclophosphamide, or busulfan and cyclophosphamide, for patients with transplant eligible lumphoid malignant conditions. The study will accrue patients until a superior method of HPCT is determined and set forth as the new standard of care. |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
- Leukemia, Myelogenous, Chronic
- Leukemia, Lymphoblastic, Acute
- Leukemia, Myelogenous, Acute
- Juvenile Myelomonocytic Leukemia
- Dysmyelopoietic Syndromes
|
- Drug: Myeloablative Chemotherapy Regimen for Lymphoid Malignancies
- Drug: Myeloablative Chemotherapy Regimen for Myeloid Malignancies
- Other: Hematopoietic Progenitor Cell Transplanation (HPCT)
|
| |
| |
| |
| Recruiting |
| 200 |
| January 2020 |
| January 2020 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Patients who are pregnant
- Inability to find a suitable donor for the patient
- Patient is HIV-positive
- Patient has active Hepatitis B
- Disease progression or relapse prior to HPC infusion
|
| Both |
| up to 21 Years |
| No |
|
|
| United States |
| |
| NCT00619879 |
| Morris Kletzel, MD, Children's Memorial Hospital |
| SCT 0307 |
| Children's Memorial Hospital |
|
| Principal Investigator: |
Morris Kletzel, MD |
Children's Memorial Hospital |
|
|
| Children's Memorial Hospital |
| August 2008 |