Trials / Unknown
UnknownNCT02014506
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents with malignant or non-malignant diseases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | 40mg/M2 once daily IV on days -7 to -2 |
| DRUG | Cyclophosphamide | 50 mg/kg IV on day -3 and -2 |
| BIOLOGICAL | anti-thymocyte globulin | |
| BIOLOGICAL | filgrastim | Beginning on day 4 and continuing until blood counts recover |
| RADIATION | Total body irradiation | 200 cGy per day on D-6 to -4 (eligible disease except aplastic anemia) 200 cGy per day on D-5 \& -4 (severe aplastic anemia) |
| PROCEDURE | TCRαβ-depleted hematopoietic cell transplantation | |
| DEVICE | CliniMACS | Immunogenetic depletion of TCRαβ cells |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2013-12-18
- Last updated
- 2017-03-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02014506. Inclusion in this directory is not an endorsement.