Phase II study of low-dose intravenous decitabine in patients aged > 60 years with acute myeloid leukemia who are not eligible for standard induction chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000069

Enrollment

200

Registered

2009-02-09

Start date

2003-04-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C92.0

Interventions

Group 1: Decitabine

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients older than 60 years with acute myeloid leukemia (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting - life expectancy > 3 months with successful treatment - performance status ECOG 0, 1, 2 - age-adjusted normal cardiac, kidney, liver function (creatinine 20 000 leukocytes/µl in whom HU cytoreduction according to the protocol is effective - signed written informed consent

Exclusion criteria

Exclusion criteria: - AML of FAB subtype M3 - previous induction-type chemotherapy for MDS or AML - previous treatment with Decitabine, or 5-azacytidine or ATRA - ´low-dose´ chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan.) within 8 weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis > 20 000/µl according to protocol - patients with > 20 000 leukocytes/µl in whom HU cytoreduction according to the protocol is ineffective - treatment with cytokines within previous 4 weeks - concomitant use of any other investigational drug - other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria) - cardiac insufficieny NYHA IV - HIV infection - other uncontrolled active infection - psychiatric disorder that interferes with treatment - known hypersensitivity to retinoids - contact lenses

Design outcomes

Primary

Measure	Time frame
tumor response	—

Secondary

Measure	Time frame
survival from start of treatment	—

Countries

Germany

Contacts

Public ContactMichael Lübbert

Universitätsklinikum Freiburg Innere Medizin - Hämatologie / Onkologie

michael.luebbert@uniklinik-freiburg.de+49 761 270-3534

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 27, 2026