Status:
COMPLETED
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Assisi Foundation
Conditions:
Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief Summary
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantatio...
Detailed Description
Secondary objectives for this study include the following: * To estimate the incidence of three transplant-related adverse outcomes (i.e., regimen-related mortality, engraftment failure, and fatal ac...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Must have one of the following diagnosis:
- AML in remission or relapse (e.g., FAB M7 or biphenotypic leukemia)
- High-risk ALL in first remission (e.g., poor responder to prednisone, Ph+ ALL)
- ALL beyond first remission
- Secondary leukemia
- Primary myelodysplasia (including RAEB, RAEB-T, CMML, JCML, and JMML)
- Chronic myeloid leukemia
- Histiocytoses (including multi-system Langerhans' cell histiocytosis and hemophagocytic lymphohistiocytosis
- Inclusion criteria Donor research participants
- HIV negative (date).
- Hepatitis B surface antigen negative (date).
- Hepatitis C antibody negative (date).
- Syphilis negative (date).
- Donor is equal to or greater than 3 on 6 HLA match (date).
- Not pregnant (negative pregnancy test).
- Not lactating.
- At least 18 years of age.
- Exclusion Criteria
- Patients greater than 24 months of age at the time of transplant.
- HLA-identical sibling donor is available.
- Cardiac function: shortening fraction \<25%.
- Pulse oximetry oxygen saturation \<92% on room air.
- Glomerular filtration rate less than 40 ml/min/1.73 m2 (may use Technetium-99 result for GFR).
- Direct bilirubin \> 3 mg/dl.
- SGPT \> 500 U/L.
- Patients with previous allergy to mouse proteins.
- Patients with previous allergy to rabbit serum products.
- Patients with Down's syndrome
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00145626
Start Date
May 1 2004
End Date
July 1 2016
Last Update
June 19 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105