A Phase I Pediatric Study of a Plerixafor Containing Regimen in Second Allogeneic Stem Cell Transplantation

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Research

Protocol

MOZBMT: A Phase I Pediatric Study of a Plerixafor Containing Regimen in Second Allogeneic Stem Cell Transplantation

Diseases

Hematologic Disorders

Description

This is a research study for patients who have cancer that affects their blood or lymphatic system. The patient received a stem cell transplant using cells obtained from a donor other than themselves. However, since the transplant procedure, the cancer came back which means the cancer may be difficult to treat or cure. In this research study, the patient will undergo a second stem cell transplant procedure. A different donor will be used.

This study will assess the safety of using a medication called plerixafor when given in children and young adults undergoing a second transplant procedure. Plerixafor has been FDA approved for use in adult patients with certain types of blood cancers who undergo autologous (using their own blood cells for the procedure.) In the adult patient population, this medication has been found to help increase the number of stem cells in these patients’ blood so that they can be collected in specific period to be reinfused after chemotherapy.

Objectives

To determine the dose- limiting toxicity and maximum tolerated dose of plerixafor in combination with fludarabine, thiotepa and melphalan as a conditioning regimen for patients undergoing a second allogeneic stem cell transplant procedure.
To evaluate the content of leukemia cells in bone marrow and in blood before and after exposure to plerixafor

Eligibility

Patients must be less than or equal to 21 years old.
Has a suitable HLA matched family member or unrelated donor available for stem cell donation. A “matched” donor is defined as matching at 5/6 or 6/6 HLA loci.
Does not have active central nervous system (CNS) malignancy (history of CNS disease allowed)

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Ashok Srinivasan, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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