Phase I, Dose Escalation Study of Decitabine
Completed · Phase 1
Conditions studied: Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid Acute, Hematopoetic Myelodysplasia
In brief
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 that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting.
Key facts
- Study ID
- NCT02264873
- Run by
- University of Florida
- People needed
- 3
- Starts
- 2014-10-01
- Expected to finish
- 2018-09-18
- Last updated by the study team
- 2018-10-15
Who can join
Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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);
You may not qualify if…
- 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;
Where it is running
- UF Health Shands Hospital — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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