drugset / Trial / NCT00629798

Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

NCT00629798

Phase 2 Completed 64 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This study will see if the researchers can lower that risk by giving the patient Palifermin. This drug helps protect the lining of the mouth, throat, and stomach. These areas typically get sores or ulcers while the blood cell counts are very low. The patient can get infections in or from these sores. Palifermin might also help the immune system recover faster. It is currently approved for patients who receive their own stem cells. That is called an autologous transplant. This study will test the use of Palifermin for T-cell depleted allogeneic stem cell transplants.

Timeline

Start
2008-02-12
Primary completion
2020-10-20
Completion
2020-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Palifermin Protein / enzyme biologic 60 ug/kg Intravenous
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic
Background Busulfan Small molecule 0.8 mg/kg Intravenous
Background Busulfan Small molecule 1 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Melphalan Small molecule 70 mg/m2 Intravenous