- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00909168
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML) (MYFLAI07)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Udine, Italy, 33100
- University Hospital, Udine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Efficacy of FLAIMy
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
Time Frame: one year
|
one year
|
RFS, DFS and OS.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
Time Frame: one year
|
one year
|
Evaluation of prognostic clinical relevance of biological features at onset.
Time Frame: one year
|
one year
|
Feasibility and outcome of consolidation with BMT.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Study Director: ANNA CANDONI, MD, UUNIVERSITY HOSPITAL, UDINE, ITALY
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MYFLAI07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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