Phase I, Dose Escalation Study of Decitabine

• Status: Completed
• Trial end date: 2018-09-18
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Hyundai Hope On Wheels
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;