Status:
COMPLETED
Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares th...
Detailed Description
OBJECTIVES: Primary * Determine the incidence of engraftment, defined as achieving donor-derived neutrophil count \> 500/mm³ by day 42, in infants with high-risk acute myeloid leukemia, acute lympho...
Eligibility Criteria
Inclusion
- Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority:
- 1st priority: 4/6 matched unit, cell dose \>5 x 10-7 nucleated cells/kg
- 2nd priority: 5/6 matched unit, cell dose \> 4 x 10-7 nucleated cells/kg
- 3rd priority: 6/6 matched unit, cell dose \> 3 x 10-7 nucleated cells/kg
- Patients aged ≤ 3 years at diagnosis (not age of transplant) with hematological malignancy as detailed below:
- Acute myeloid leukemia: high risk CR1 as evidenced by:
- High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (\>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., \<15% blasts in BM).
- Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); \>1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND \<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
- Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be \< 10% by a representative bone marrow aspirate morphology.
- Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: Patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy. MRD will be defined by either flow cytometry (\>0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (PCR or FISH) or conventional cytogenetics (g-banding).
- New Leukemia Subtypes: A major effort in the field of pediatric hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
- Recipients must have a Lansky score ≥ 50% and have acceptable organ function defined as:
- Renal: glomerial filtration rate \> 60ml/min/1.73m\^2
- Hepatic: bilirubin, AST/ALT, ALP \< 5 x upper limit of normal,
- Pulmonary function: oxygen saturation \>92%
- Cardiac: left ventricular ejection fraction \> 45%.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Exclusion
- Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days).
- History of HIV infection or known positive serology
- Myeloablative transplant within the last 6 months.
- Evidence of active extramedullary disease (including central nervous system leukemia).
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00357565
Start Date
November 1 2005
End Date
March 11 2025
Last Update
August 26 2025
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455