Clinical trial · Interventional
Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk
Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk
- 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)
The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.
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 |
|---|---|---|---|
| gemtuzumab ozogamycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- gemtuzumab ozogamycin
- description
- Initial randomization will be completed upon receipt of karyotype results and will determine the administration of gemtuzumab ozogamycin (MYLOTARG ®) in combination with chemotherapy during the induction course and the first intensive consolidation course.
- interventionNames
- Drug: gemtuzumab ozogamycin
- type
- NO_INTERVENTION
- label
- without Mylotarg
Primary outcomes (1)
- measure
- event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation
- timeFrame
- 3 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with de novo AML and intermediate risk as defined by the cytogenetics criteria of GOELAMS Group: * Normal karyotype or * Karyotype with other abnormalities, excluding the favourable group \[t (15; 17), t (8; 21), inv (16)\] and the high risk group \[(-5/5q-, -7/7q- , t (9.22), t (6.9), 11q23 anomaly excluding the t (9; 11), abnormal 3q, complex karyotype (\> 3 abnormalities)\]. Not previously treated for AML. * Patients aged 18 to 60 years * And having more than 20% of blast cells in bone marrow and as previously described. * And with intermediate cytogenetics as previously defined * And whose expression of the CD33 antigen on the blasts was defined using standard method * And with a WBC \<or equal to 100G/L. * And who can receive either one or the other of the treatments under study * And having a good performance status (WHO score \<3) with a life expectancy greater than one month. * Affiliated with the Social Security Exclusion Criteria: * Patients aged under 18 or over 60 years * OR with AML: * Not classifiable in the classification French-American-British (FAB) * Type M3 * Or blastic transformation of a myeloproliferative or myelodysplastic syndrome previously diagnosed * Outside the intermediate cytogenetic group as previously defined * OR with isolated extramedullary localization of their disease * OR WBC\> 100G / L * Patients with known human immunodeficiency virus (HIV) infection or human T-lymphotrophic virus 1 (HTLV-1) * Patients with SGOT/SGPT \>5N * Patients with a calculated creatinine clearance of \<50 mL/min * Informed consent refusal * Pregnant and/or lactating female
References
Publications (0)
Data not yet available