Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk

Phase 2

Completed

• Conditions: acute leukemia; myelodysplasia; 10024324

• Registration Number: NL-OMON42455
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-10
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

- patients with AML or high risk MDS (IPSS-R >= 4.5)
- > 65 years
- WHO performance score 0-2
- HCT-CI score >=2
- Written informed consent

Exclusion Criteria

- Previous treatment with decitabine, azacitidine or intensive chemotherapy for this MDS/AML (treatment with chemotherapy for previous other diseases is acceptable)
- Acute promyelocytic leukemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Day 30 mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Remission status after one cycle of decitabine-cytarabine<br /><br>• Remission status after two cycles of decitabine-cytarabine</p><br>