newly diagnosed (untreated) and CD 33 positive AML, under 66 years. MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia
Conditions
Interventions
Trade Name: MYLOTARG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemtuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: FLUDA
Sponsors
AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed