Acute myeloid leukemia and high risk myelodysplasia
Conditions
Interventions
Product Name: Cytarabine
Product Code: RVG 11013
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cytarabine
CAS Number: 69-74-9
Other descriptive name: CYTARABINE HYDROCHLORIDE
Concent
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Remission status after one cycle of decitabine-cytarabine • Remission status after two cycles of decitabine-cytarabine ;Timepoint(s) of evaluation of this end point: Day 90 after start of chemotherapy | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Leiden University Medical Center
Outcome results
None listed