Recruitment

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