Clinical trial · Interventional
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLAIMy - Fluda, Ida, Ara-C, Mylotarg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Efficacy of FLAIMy
- interventionNames
- Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg
Primary outcomes (2)
- measure
- Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
- timeFrame
- one year
- measure
- RFS, DFS and OS.
- timeFrame
- one year
Secondary outcomes (3)
- measure
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCandoni A, Papayannidis C, Martinelli G, Simeone E, Gottardi M, Iacobucci I, Gherlinzoni F, Visani G, Baccarani M, Fanin R. Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2. PMID 29396857