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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23606

Enrollment

Registered

2016-01-13

Start date

2016-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML), Myelodysplasia (MDS), Acute myeloide leukemie, Myelodysplasie, Chemotherapy, Chemotherapie

Interventions

Patients will receive decitabine one time daily 20 mg/m2 during 5 days, directly followed by cytarabine 100 mg/m2 per day as continuous infusion during 5 days. At day 28-35 after the start of chemothe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with AML or high risk MDS (IPSS-R ¡Ý 4.5) 2. > 65 years 3. WHO performance score 0-2 4. HCT-CI score >=2 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous treatment with decitabine, azacitidine or intensive chemotherapy for this MDS/AML (treatment with chemotherapy for previous other diseases is acceptable) 2. Acute promyelocytic leukemia

Design outcomes

Primary

Measure	Time frame
Mortality at day 30 after start of decitabine-cytarabine chemotherapy	—

Secondary

Measure	Time frame
Remission status after one and two cycles of decitabine-cytarabine	—

Contacts

Public ContactP.A. Borne, von dem

Leids Universitair Centrum, Afdeling Hematologie C2-R, Albinusdreef 2

P.A.von_dem_Borne@lumc.nl071-5262267

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)