A Phase I/II Trial of Clofarabine, Melphalan, and Thiotepa Followed by an Allogeneic Stem Cell Transplant for the Treatment of High-Risk and/or Advanced Hematologic Malignancies

Protocol
06-125
Full Title
Phase I/II Dose Escalation Trial of Clofarabine, in Addition to Melphalan & Thiotepa as Myeloablative Regimen Followed by Allogeneic Unmodified HSCT from HLA-Compatible Related/Unrelated Donors Treatment of High Risk and/or Hematologic Malignancies
Phase
I/II
Purpose

This study is assessing a new way of treating patients with leukemia or myelodysplastic syndrome (MDS) that has recurred, is resistant to chemotherapy, or has a high risk of relapsing. The treatment involves adding the relatively new chemotherapy drug clofarabine to standard antileukemic treatment with melphalan and thiotepa before stem cell transplantation.

Researchers want to determine the optimal and safest dose of clofarabine that can be given with the other two drugs to eliminate the diseased bone marrow with the transplant. Once the highest safe dose of clofarabine is identified, they also want to determine the effectiveness of this combination of drugs and stem cell transplantation for preventing leukemia or MDS from returning.

Eligibility

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

  • Patients must have a confirmed diagnosis of leukemia that has returned or no longer responds to treatment, or MDS that has a high risk of recurring following transplant.
  • Patients must be younger than age 55. (Those ages 55 and older will be considered on a case-by-case basis.)
  • Patients may have had one prior stem cell transplant that must have been conducted at least 6 months before the second transplant.
  • Patients must have an HLA closely matched related or unrelated donor.

For more information and to see if you are or your child is eligible for this study, please contact Dr. Farid Boulad at 212-639-6684 or Dr. Esperanza Papadopoulos at 212-639-8276.

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