Protocol

REFLEX: Haploidentical hematopoietic stem cell transplantation using a novel Clofarabine containing conditioning regimen for patients with refractory hematologic malignancies

Diseases

Leukemias / Lymphomas : Acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML), Hodgkin lymphoma, non-Hodgkin lymphoma, myelodysplastic syndrome (MDS)

Description

This is a pilot study to determine the maximum tolerated dose of clofarabine when used in combination with melphalan and thiotepa conditioning regimen. The total length of time of the actual treatment in this study is 4 to 6 months. However, some routine evaluations and research testing will continue until about 5 years after transplantation. Participants in this study will also be assessed in a annual follow-up visit after administering this procedure to children and adolescents with refractory hematological malignancies.

The treatment involved in this study has the following parts;

  • Conditioning treatment which includes administration of clofarabine, the drug under study.
  • Stem cells will be collected from a family member donor.
  • The stem cells will be processed and filtered (“selected”) before they are given.
  • Infusion of the donor stem cells - “the transplant.”
  • Additional white blood cells from the donor called donor lymphocytes in the event you experience a condition called graft insufficiency.
  • Additional donor stem cells in the event of graft failure or graft rejection.

Objectives

  • To determine the maximum tolerated dose and dose limiting toxicity of clofarabine in combination with thiotepa and melphalan as a conditioning regimen for haploidentical HSCT with an engineered graft depleted of CD3+ cells obtained by negative selection with OKT3 on the CliniMACS system.
  • To describe the one-year overall survival and event-free survival rates in these study participants

Eligibility

  • Age less than or equal to 21 years old; may be greater than 21 years old if a previously treated St. Jude patient and within 3 years of completion of most recent prior disease specific therapy.
  • Does not have any other active malignancy other than the one for which this transplant is indicated.
  • One of the following refractory hematologic malignancies or diagnoses:
    • ALL
    • AML (>25% blasts in the bone marrow)
    • secondary AML/MDS
    • CML in accelerated phase or blast crisis
    • juvenile myelomonocytic leukemia (JMML)
    • myelodysplastic syndrome (MDS)
    • Hodgkin or non-Hodgkin lymphoma (NHL) with residual or recurrent disease following autologous HSCT unable to undergo autologous HSCT due to chemoresistant disease or inability to have an acceptable quantity of tumor-free stem cells collected
    • patients with a hematologic malignancy who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the opinion of the PI makes standard myeloablation prohibitive.

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

Wing Leung, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice:   1-866-2ST-JUDE  (1-866-278-5833)
FAX:     901-495-5068

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

Initial Version dated 6.01.08, IRB approved 12.18.08


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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