drugset / Trial / NCT00281879
Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
Phase 2
Terminated
200 enrolled
OHSU Knight Cancer Institute
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or methylprednisolone may stop this from happening. PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer.
Timeline
- Start
- 2006-02
- Primary completion
- 2008-02
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Comparator | Busulfan | Small molecule | 0.8 mg/kg | Oral |
| Comparator | Busulfan | Small molecule | 1 mg/kg | Oral |
| Comparator | Busulfan | Small molecule | 3 mg/kg | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Cytarabine | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 50 mg/kg | Intravenous |
| Comparator | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Comparator | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Comparator | carmustine | Small molecule | 300 mg/m2 | Intravenous |
| Comparator | Cyclosporine | Peptide | 1.5 mg/kg | Intravenous |
| Comparator | Methotrexate | Small molecule | — | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | — | Intravenous |
| Comparator | Mycophenolate Mofetil | Small molecule | — | Oral |
| Comparator | Tacrolimus | Small molecule | — | — |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |