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

Acute Myeloid Leukemia Clinical Trial

— MYFLAI07  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909168
• Other study ID #: MYFLAI07
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 26, 2009
• Last updated: May 5, 2014
• Start date: March 2008
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: University Hospital, Udine, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2013
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• FLAIMy - Fluda, Ida, Ara-C, Mylotarg
FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5 ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5 IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5 GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6

Locations

Country	Name	City	State
Italy	University Hospital, Udine	Udine

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Udine, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.		one year	Yes
Primary	RFS, DFS and OS.		one year	Yes
Secondary	Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.		one year	Yes
Secondary	Evaluation of prognostic clinical relevance of biological features at onset.		one year	Yes
Secondary	Feasibility and outcome of consolidation with BMT.		one year	Yes