A phase III trial in adult acute myelogenous leukemia AML comparing 1 standard-dose versus high-dose remission induction therapy and 2 , within a risk-oriented postremission strategy, an autologous blood stem cell transplantation versus an autologous blood stem cell-supported multicycle high-dose program Protocol NILG-AML 02/06 . - ND

• Conditions: PATIENT WHIT LMA; MedDRA version: 8.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloid

• Registration Number: EUCTR2006-003817-42-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

FOR R1 1. A diagnosis of untreated AML or high-risk MDS is required. 2. The diagnosis must be one of o de novo AML and variants thereof including rare diagnostic subsets , o secondary AML, o MDS-related AML or high-risk MDS RAEB-2 by WHO criteria , o primary myeloid sarcoma MS 3. Age 16 years. 4. ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures. 5. Informed consent signed by the patient or by a parent/tutor in patients aged 18 years. FOR R2 1. Confirmed CR status after Random 1 check of BM and PB morphology 2. Sufficient amount of autologous blood stem cells 2 x106/kg following A8 consolidation/mobilization chemotherapy cycle no. 3 3. Age 65 years 4. Signed informed consent by the patient or by parent/tutor in patients aged 18 years 5. SR risk class or HR risk class if ineligible to or unable to proceed to allogeneic SCT 6. Functional echocardiography of the left ventricle with ejection fraction 50
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

FOR R1 1. Diagnosis of acute promyelocytic leukemia. 2. Pre-existing, uncontrolled pathology such as heart failure congestive/ischaemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV , severe liver disease with serum bilirubin 3 mg/dL and/or ALT 3 x upper normal limit unless attributable to AML , kidney function impairment with serum creatinine 2 mg/dL unless attributable to AML , and severe neuropsychiatric disorder that impairs the patient s ability to understand and sign the informed consent, or to cope with the intended treatment plan. 3. Pre-existing HIV positive serology i.e. already known before enrolmentA history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy 1 year. 4. Pregnancy FOR R2 1. Unresolved hematological or extrahematological toxicity of CTC-NCI Common Toxicity Criteria from the National Cancer Institute grade II or greater 2. Unresolved/unimproved bacterial or fungal infections from prior therapy, involving major anatomical sites central nervous system, respiratory tract, gastrointestinal system, genito-urinary system, soft tissues and muscolo-skeletal structures and requiring patient hospitalization with use of parenteral antimicrobial and antifungal drugs

Study & Design

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