drugset / Trial / NCT00008151
Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Treatment
Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome.
Timeline
- Start
- 2000-10
- Primary completion
- 2002-07
- Completion
- 2002-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Oral |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |