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

• Conditions: Acute myeloid leukemia and high risk myelodysplasia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-004896-60-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS =1.5) with a high risk of early mortality (HCT-CI score >=2);Secondary Objective: To evaluate remission status after one and two cycles of decitabine-cytarabine;Primary end point(s): • Day 30 mortality ;Timepoint(s) of evaluation of this end point: Day 30 after start of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Remission status after one cycle of decitabine-cytarabine<br>• Remission status after two cycles of decitabine-cytarabine<br>;Timepoint(s) of evaluation of this end point: Day 90 after start of chemotherapy