Status:
COMPLETED
Stem Cell Transplantation for Patients With Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Lymphoblastic Leukemias
Acute Myelocytic Leukemia
Eligibility:
All Genders
2-21 years
Phase:
PHASE3
Brief Summary
Childhood leukemias which cannot be cured by chemotherapy alone may be effectively treated by allogeneic bone marrow transplantation. Moreover, for patients with chronic myelogenous leukemia (CML), al...
Detailed Description
Secondary outcome evaluations for this clinical study include the following: * To estimate the overall survival in patients with high risk hematological malignancies who receive a HSCT with an unmani...
Eligibility Criteria
Inclusion
- All patients lacking an HLA identical sibling for whom an unrelated donor matched at 6/6 HLA loci is formally requested within about 3 months of search initiation
- Age greater than or equal to 24 months, but less than 21 years for new patients.
- Diagnosis of one of the following high risk hematological malignancies:
- Acute lymphoblastic leukemia (in second or subsequent remission or high risk in first remission)
- Acute myeloid leukemia (in relapse or remission)
- Secondary AML/MDS
- Chronic myeloid leukemia
- Juvenile myelomonocytic leukemia
- Myelodysplastic syndrome
- Paroxysmal nocturnal hemoglobinuria
- Non-Hodgkin's lymphoma (in second or subsequent remission)
Exclusion
- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram, or cardiac shortening fraction below 25%
- Patients with renal creatinine clearance \< 40ml/min/1.73m\^2
- Patients with FVC \< 40% predicted or pulse oximetry less than or equal to 92% on room air if unable to perform pulmonary function tests
- Patients with direct bilirubin \> 3 mg/dl
- Patients with SGPT \> 500 U/L
- Patients with a Karnofsky or Lansky performance score \< 70
- Patients who have received a previous allogeneic stem cell transplant
- Patients with a known allergy to rabbit or murine products
- Patients with isolated extramedullary leukemic relapse, including isolated CNS or testicular recurrence
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00152139
Start Date
May 1 2002
End Date
January 1 2009
Last Update
January 29 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105