Clinical trial · Interventional
Phase I, Dose Escalation Study of Decitabine
Minimizing Leukemia Relapse: A Phase I, Dose Escalation Study of Decitabine in High Risk Pediatric Leukemia Post Allogeneic Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Decitabine
- description
- This is a 3+3 design of dose escalation
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- Maximum Tolerated Dose as a Measure of Safety and Tolerability
- timeFrame
- 3 months
- description
- This is a dose escalation study of decitabine maintenance therapy after allo-HSCT for the maximally tolerated dose in pediatric patients without adverse events.
Secondary outcomes (2)
- measure
- Adverse Event Profile After Single Cycle Decitabine Post Transplant
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available