Acute Myeloid Leukemia Clinical Trial
— MYFLAI07Official title:
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital, Udine | Udine |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Udine, Italy |
Italy,
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 |
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