drugset / Trial / NCT00669890
Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML
NaSingle-groupOpen-labelTreatment
Summary
The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated. This study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)
Timeline
- Start
- 2004-05
- Primary completion
- 2012-12
- Completion
- 2013-12
Outcome
Outcome not reported
Stopped: “PI left institution”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | — | — |
| Background | Busulfan | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |
| Background | Thymoglobulin | Protein / enzyme biologic | — | — |