Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of in-duction therapy for adult patients with acute myeloid leukemia =65 years

Phase 1

• Conditions: ewly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In acute erythroid leukemia, =20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.Patients at the age of 18 to 65 years.; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10066353Term: Treatment related acute myeloid leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10000887Term: Acute myeloid leukemia in remissionSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10054294Term: Acute myeloid leukemia (in remission)System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003191-12-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-26
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

- Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In acute erythroid leukemia, =20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
- Age 18-65 years
- ECOG performance status 0-2
- Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 10 days prior to Day 1/Baseline:
o Total bilirubin = 1.5 times the upper limit of normal
o ALT and AST = 2.5 times upper limit of normal
o Creatinine = 1.5 times upper limit of normal
- Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of = 50% as assessed by transthoracal twodimensional echocardiography (M Mode”) or MUGA scan
- Signed Informed Consent
- Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
o Post-menopausal (12 months of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
o Sexual abstinence
o Vasectomy of the sexual partner
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 568
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 568

Exclusion Criteria

- Patients who are not eligible for standard chemotherapy as assessed by the treating physician
- Central nervous system manifestation of AML
- Cardiac disease: i.e. heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Patients undergoing renal dialysis
- Chronic pulmonary disease with clinical relevant hypoxia
- Known HIV or Hepatitis infection
- Uncontrolled active infection
- Medical conditions other than AML with an estimated life expectancy below 6 months
- Previous treatment of AML except hydroxyurea up to 5 days
- Relapsed or primary refractory AML
- Acute promyelocytic leukemia
- Previous anthracyclin-containing chemotherapy
- Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
- Incapability of understanding purpose and possible consequences of the trial
- Pregnant or breastfeeding women
- Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)

Study & Design

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