drugset / Trial / NCT00027820
Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
Phase 1/2
Completed
106 enrolled
Fred Hutchinson Cancer Center
National Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.
Timeline
- Start
- 2001-08
- Primary completion
- 2004-09
- Completion
- 2004-09-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Cyclosporine | Peptide | — | Oral |
| Background | Fludarabine | Small molecule | — | Intravenous |
Indications
B-cell chronic lymphocytic leukemia
Hodgkins lymphoma
adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia
childhood kidney cell carcinoma
childhood myelodysplastic syndrome
chronic myelomonocytic leukemia
clear cell renal carcinoma
kidney medullary carcinoma
myelodysplastic syndrome with ring sideroblasts
papillary renal cell carcinoma
plasma cell neoplasm