Status:
COMPLETED
Phase I, Dose Escalation Study of Decitabine
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Hyundai Hope On Wheels
Conditions:
Leukemia, Lymphoblastic, Acute
Leukemia, Myeloid Acute
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
Brief Summary
Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis tha...
Detailed Description
Decitabine is a hypomethylating agent with significant anti-leukemic effect in MDS and AML. Additionally, aberrant DNA methylation has been identified in high risk childhood ALL, and therefore, DNA hy...
Eligibility Criteria
Inclusion
- Age: greater than 1 and less than 31 years of age;
- Diagnosis: history of ALL, AML or MDS, currently in a complete remission (CR) following allo-HSCT (bone marrow leukemic blasts less than 5% by morphology), with high risk features including:
- Status post allogeneic HSCT
- GVHD prophylaxis:
- Karnofsky or Lansky performance scores more than 50%. Karnofsky scores will be used for patients \> 16 years of age and Lansky scores for patients ≤ 16 years of age;
- Platelet count ≥ 50,000 (untransfused);
- Absolute neutrophil count ≥ 1000; and;
- Hemoglobin ≥ 8 g/dL (un-transfused);
Exclusion
- Progressive disease;
- Philadelphia chromosome positive ALL (these patients receive tyrosine kinase inhibitor posttransplant);
- Known hypersensitivity to any components of decitabine;
- Uncontrolled grade 3-4 graft versus host disease;
- Uncontrolled infection;
- Serum creatinine \> 2 mg/dL or glomerular filtration rate (GFR) less than 60 mL/min/1.73m2 ;
- Alanine Aminotransferase (ALT) greater than 3 times normal or serum total bilirubin greater than 2 mg/dL;
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02264873
Start Date
October 1 2014
End Date
September 18 2018
Last Update
October 15 2018
Active Locations (1)
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1
UF Health Shands Hospital
Gainesville, Florida, United States, 32610