drugset / Trial / NCT00038857
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
NaSingle-groupOpen-labelTreatment
Summary
Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease \[GvHD\] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.
Timeline
- Start
- 2001-09
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Fludarabine | Small molecule | 160 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | Thiotepa | Other / unclassified | 10 mg/kg | — |
| Background | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |