INDUCTION, CONSOLIDATION AND INTENSIFICATION PROTOCOL FOR PATIENTS YOUNGER THAN 66 YEARS WITH PREVIOUSLY UNTREATED CD33 POSITIVE ACUTE MYELOID LEUKEMIA (AML) - ND

Phase 1

Conditions: newly diagnosed (untreated) and CD 33 positive AML, under 66 years.
MedDRA version: 9.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia

Registration Number: EUCTR2007-005248-26-IT

Lead Sponsor: AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age 18-65 years. WHO PS grade 0-2 or Karnofsky > 70. AML according to the new WHO criteria, i.e. % of BM blasts ≥ 20%. All FAB subtypes except M3. CD33 positivity (> 20%). It is mandatory to perform an immunothyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor. Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS). Adequate renal and liver function, i.e. creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Blast crisis of chronic myeloid leukemia. AML supervening after other myeloproliferative diseases. AML de novo or secondary previously pretreated. Concomitant malignant disease. Active central nervous system (CNS) leukemia. Active uncontrolled infection [NB severe systemic infection should be excluded]. Concomitant severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease. Cardiac ejection fraction of 50% or less. Severe pulmonary dysfunction (CTC grade 3-4). Severe concomitant neurological or psychiatric disease. History of alcohol abuse. HIV positivity. Pregnancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate prospectively the antileukemic activity and toxicity of a treatment strategy combining an antibody-targeted cytotoxic agent and standard intensive chemotherapy;Secondary Objective: Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring Evaluation of prognostic clinical relevance of biological features at onset. Faesibility and outcome of consolidation with BMT.;Primary end point(s): Faesibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin. RFS, DFS and OS.

Secondary Outcome Measures