Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

Trial is based on:

• INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).

• CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)

• INTENSIFICATION: Allo-BMT, ASCT

• MAINTENANCE: AraC

a) Primary endpoints:

• Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.

• RFS, DFS and OS.

b) Secondary endpoints:

• Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.

• Evaluation of prognostic clinical relevance of biological features at onset.

• Feasibility and outcome of consolidation with BMT.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Udine, Italy
• Treatments: Gemtuzumab

Criteria

Inclusion Criteria:

• Age 18-65 years.

• WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.

• AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy

• All FAB subtypes except M3.

• CD33 positivity (> 20%). It is mandatory to perform an immunotyping 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.

• Written informed consent

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.

• Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.

• Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.