Stem cell transplantation has improved the outcome for pediatric patients with hematologic malignancies. Stem cells are immature blood cells that can develop into many different cell types. The best type of donor for a stem cell transplant is a brother or sister who is a “match” for the subject’s immune type (HLA type). Many subjects do not have an HLA-matched sibling and are not able to wait for an unrelated HLA-matched donor to become available. Most subjects do have an available “mismatched” family member donor (haploidentical donor).

In the past, many serious complications have occurred in patients receiving a haploidentical stem cell transplant. During the last five years, studies have been done with patients who had high-risk disease, patients with refractory (returned after treatment) disease, and patients receiving their second transplant. The favorable results from these studies have encouraged researchers to develop this study.

Patients who participate in this study will receive a graft (donated stem cells) which has been processed to remove specific cells which contribute to adverse reactions in the recipient’s body. The goal of this clinical trial will be to improve the overall survival and reduce the relapse rates in research participants undergoing haploidentical stem cell transplantation.

Condition	Intervention	Phase
Neoplasm, leukemia, myeloid Lymphoma, Non-Hodgkin Stem Cell Transplantation Myelodysplastic Syndromes Hepatic Cancer	Drug: Muromonab-CD3, Thiotepa, Methylprednisolone, Fludarabine  Procedure: Stem Cell Transplantation  Device: Miltenyi, CliniMACS	Phase II

Further Study Details: 

Primary Outcomes: To measure the rate of disease relapse at six months for participants that receive a processed haploidentical stem cell transplant
Secondary Outcomes: Researchers will study the one-year survival rate, disease-free and event free survival of participants following this type of stem cell transplant
Expected Total Enrollment:  15

Ages Eligible for Study:  2 Years   -   21 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patient does not have a matched identical sibling or a matched unrelated donor available
• Patient has a mismatched family member donor
• Patient has a high-risk hematologic malignancy (cancer to the blood)
• Patient has a hematologic malignancy which has returned after treatment
• Adequate function of the heart, kidney and liver

Exclusion Criteria:

• Active central nervous system leukemia

Please refer to this study by ClinicalTrials.gov identifier  NCT00143559

Gregory Hale, M.D.      1-866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting

Study chairs or principal investigators

Gregory Hale, M.D.,  Principal Investigator,  St. Jude Children''''s Research Hospital   

Study ID Numbers:  HAPREF
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143559
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06