HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
N/A
24 Months
Both
Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplasia, Chronic Myeloid Leukemia, Histiocytosis
Trial Information
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
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 acute GVHD) in the first 100
days after transplantation.
- To estimate the incidence of chronic graft-versus-host disease.
- To evaluate those factors that affect one-year survival.
- To assess the kinetics of lymphohematopoietic reconstitution.
- To assess the frequency and clinical relevance of minimal residual disease (MRD) before
and after transplantation.
- To evaluate the incidence of and risk factors for long-term neurocognitive deficit and
organ dysfunction.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a non-TBI based preparative regimen and T-lymphocyte depleted graft with a subsequent infusion of donor NK cells.
Outcome Time Frame:
5 Years
Safety Issue:
Yes
Principal Investigator
Wing H. Leung, M.D., PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Food and Drug Administration
Study ID:
INF-T2
NCT ID:
NCT00145626
Start Date:
May 2004
Completion Date:
May 2014
Related Keywords:
- Acute Myeloid Leukemia
- Acute Lymphocytic Leukemia
- Myelodysplasia
- Chronic Myeloid Leukemia
- Histiocytosis
- Stem cell transplantation
- Stem cell transplant
- Haploidentical transplant
- Histiocytosis
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myelodysplastic Syndromes
- Preleukemia
- Hematologic Neoplasms
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
