Evaluation of Efficacy and Toxicity of Intensified Consolidation Therapy in AML Patients =60 Years

• Conditions: Acute myeloid leukemia (AML), de novo, FAB classification other than M3 or WHO classification other than APL t(15,17), > 60 years, abesence of any other antededent hematologic disease of >8 months, ECOG performance status 0, 1 or 2, life expectancy > 3 months, adequate organ functions to receive intensive chemotherapy; MedDRA version: 17.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005806-29-AT
• Lead Sponsor: Medical University of Vienna, Dep. of Internal Medicine I, division of Hematology & Hemostaseology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-14
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patients must have a morphologically confirmed diagnosis of AML with FAB classification other than M3 or WHO classification other than APL t(15;17), based on bone marrow aspiration and biopsy.
•Patients must have reached their 60th birthday.
•ECOG performance status of 0, 1, or 2.
•Life expectancy >3 months
•Adequate organ function to receive intensive chemotherapy
•Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

•Patients with APL
•Subjects with blast transformation of chronic myeloid leukemia or leukemia developing from myeloproliferative diseases.
•Leukemia following a documented myelodysplasic syndrome known for more than 8 months.
•Patients with a concurrent malignancy, except stage 1 cervical intraepithelial carcinoma and basal cell carcinoma.
•Previous treatment with chemotherapy.
•Patients who have known HIV-infection.
•Impaired hepatic or renal function i.e.: ALT and/or AST > 2.5 x ULN; bilirubin > 2 x ULN; Serum creatinin > 2 x ULN (after adequate hydration) (unless these are most likely caused by AML organ infiltration)
•Severe cardiac disease: Patients must not have a severely reduced left ventricular function (shortening fraction <20% as assessed by 2-D ECHO within 6 months prior initiation of induction therapy), unstable cardiac arrhythmias or unstable angina.
•Severe obstructive or restrictive pulmonary disease.
•Patients must not have received systemic chemotherapy or more than one dose of intrathecal chemotherapy for acute leukemia. Administration of hydroxyurea or etoposid to control high blast cell counts prior to induction-chemotherapy is permitted.
•Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for this study.
•Concerns for subject’s compliance with the protocol procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified