Clinical trial · Interventional
DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML
A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia
- 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)
For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients \> 50 and \<70 years.
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 |
|---|---|---|---|
| Mylotarg | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DAUNORUBICINE - ARACYTINE - MYLOTARG -
- description
- Adaptive Bayesian method for dose-finding in phase I/II clinical trials based on treatment efficacy and toxicity (Thall, Russel, 1998), with successive patients cohorts and three combined dose levels: DNR 45 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 200 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. Two consolidation courses for CR patients: Amsacrine: 90 mg/m2 IV Day 1 Cytarabine: 1g/m2 twice a day IV Days 1 to 4 Mylotarg: 3 mg/m2 IV Day 1.
- interventionNames
- Drug: Mylotarg
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT) defined by the occurrence of any G3 or G4 non reversible toxicity at day 45 excluding myelosuppression or infection due to neutropenia, and response defined by complete remission at day 45
- timeFrame
- Day 45 post first dose of treatment
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Patients with a morphologically proven diagnosis of CD33-positive AML and : 1. Age ≥ 50 years and ≤ 70 years. 2. First relapsing AML with a duration of first CR ≥ 3 and ≤18 months 3. ECOG performance status 0 to 3 4. Negative serology HIV, HBV and HBC (except post vaccination) 5. Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N 6. Cardiac function determined by radionuclide or echography within normal limits. 7. Negative serum pregnancy test within one week before treatment for women of child bearing potential 8. Signed informed consent. Exclusion Criteria: 1. M3-AML 2. AML following diagnosed myelodysplastic syndrome or myeloproliferation 3. Known central nervous system involvement with AML 4. Prior treatment with HSCT. 5. Previous treatment with Anti CD33 antibodies 6. Uncontrolled infection 7. Other active malignancy
References
Publications (0)
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