Clinical Trials

A Phase II Study of Peri-transplant Palifermin followed by an Allogeneic T-Cell-Depleted Stem Cell Transplant in Patients with Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Evolved from MDS

Protocol
08-008
Full Title
A Phase II Trial of 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) Evolved from MDS
Purpose

An infusion of stem cells from a donor — an allogeneic stem cell transplant — is one way of treating acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). One potential complication of stem cell transplantation is graft-versus-host disease (GvHD), an immune reaction that occurs when T cells (white blood cells) from the donor attack the recipient’s tissues and organs.

Removing the T cells (T cell depletion) from the donor’s stem cell transplant lowers the risk of GvHD but may also increase the recipient’s risk of infection. Researchers in this study want to determine if giving transplant recipients a drug called palifermin can reduce the risk of infection. This drug helps protect the lining of the mouth, throat, and stomach, which typically develop sores or ulcers after high dose chemotherapy and when blood cell counts are very low. Palifermin might also help the patient’s immune system recover more quickly. The drug is already approved for transplant patients who receive their own stem cells (autologous transplantation).

Patients in this study will include those with advanced myelodysplastic syndromes (refractory anemia with excess blasts 1 and 2) and acute myeloid leukemia (AML) evolved from MDS.

Investigator
Hugo R. Castro-Malaspina, MD
Hugo R. Castro-Malaspina - Physician Profile
Co-Investigators
Farid Boulad, MD -- Medical Director, Pediatric Day Hospital
Farid Boulad - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) evolved from MDS.
  • Patients must have a related or unrelated HLA-matched or partially mismatched stem cell donor.
  • Patients may not have received a stem cell transplant in the 6 months before entering the study.
  • Patients must be younger than age 65.

For more information and to inquire about eligibility for this study, please contact Dr. Hugo Castro-Malaspina at 212-639-8197.

Disease(s)
Blood & Marrow Stem Cell Transplantation: Sibling and Unrelated Volunteer
Blood and Marrow Transplantation: Transplantation
Hematology: Myelodysplastic Syndrome
Leukemia: Acute Myelogenous Leukemia
Locations
ClinicalTrials.gov
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