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

Phase 2

• Conditions: C92.0; Acute myeloblastic leukaemia [AML]

• Registration Number: DRKS00000069
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 235

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 < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
- patients with >20 000 leukocytes/µl in whom HU cytoreduction according to the protocol is effective
- signed written informed consent

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tumor response

Secondary Outcome Measures

Name	Time	Method
survival from start of treatment