Status:
COMPLETED
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
Lead Sponsor:
University Hospital, Udine, Italy
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 + Gem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00909168
Start Date
March 1 2008
End Date
March 1 2013
Last Update
May 6 2014
Active Locations (1)
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1
University Hospital, Udine
Udine, Italy, Italy, 33100