The Use of Decitabine as Induction Therapy for Acute Myeloid Leukemia With Complex and/or Monosomal Karyotype
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Complex Karyotype
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
This is an open-label interventional study to study the use of decitabine as induction therapy for acute myeloid leukemia with complex and/or monosomal karyotype. Subjects will receive decitabine for every 28 days, until disease progression or a bone marrow transplantation is carried out, in the sch...
This is an open-label interventional study to study the use of decitabine as induction therapy for acute myeloid leukemia with complex and/or monosomal karyotype. Subjects will receive decitabine for every 28 days, until disease progression or a bone marrow transplantation is carried out, in the schedule as below: Cycle 1: Receive decitabine for 10 days Cycle 2 and Cycle 3: Based on the result of bone marrow examination, subjects may receive decitabine for 5 days or 10 days Cycle 4 until disease progression: Rdecitabine for 5 days. Subjects may also resume a 10 day treatment after cycle 6 if their physician judged as appropriate. The drug will then be administrated intravenously. Blood will be drawn every 7 days and bone marrow extraction would be done on Day 28 (+/- 3days) from the day 1 of each cycle of treatment for examination.
Tracking Information
- NCT #
- NCT03080766
- Collaborators
- Janssen, LP
- Investigators
- Principal Investigator: Anskar Leung, Professor The University of Hong Kong