Clinical trial · Interventional
Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- GO + MICE for remission induction followed by GO + mini-ICE for consolidation
- interventionNames
- Drug: cytarabine
- Drug: etoposide
- Drug: gemtuzumab ozogamicin
- Drug: idarubicin
- Drug: mitoxantrone hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- MICE for remission induction followed by mini-ICE for consolidation
- interventionNames
- Drug: cytarabine
- Drug: etoposide
- Drug: idarubicin
- Drug: mitoxantrone hydrochloride
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML)
* Bone marrow blasts at least 20% by bone marrow aspiration or biopsy
* FAB subtypes M0-M2 and M4-M7
* No acute promyelocytic leukemia (FAB subtype M3)
* Previously untreated primary or secondary AML, including AML after myelodysplastic syndromes
* Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed
* No blast crisis of chronic myelogenous leukemia
* No AML supervening after other myeloproliferative diseases
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
* 61 to 75
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC less than 30,000/mm\^3 (pretreatment with hydroxyurea for no more than 14 days allowed)
Hepatic
* Bilirubin no greater than 3 times upper limit of normal (ULN)
Renal
* Creatinine no greater than 3 times ULN
Cardiovascular
* No concurrent severe cardiovascular disease
* No arrhythmias requiring chronic treatment
* No congestive heart failure
* No symptomatic ischemic heart disease
Pulmonary
* No severe pulmonary dysfunction (CTC grade 3-4)
Other
* HIV negative
* No other uncontrolled infection
* No other concurrent malignant disease
* No severe concurrent neurological or psychiatric disease
* No prior alcohol abuse
* No psychological, familial, sociological, or geographical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent hematopoietic growth factors (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except for life-threatening infection due to neutropenia
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior enrollment in this trialReferences
Publications (1)
- DERIVEDAmadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P, De Fabritiis P, Venditti A, Ho AD, Lubbert M, Thomas X, Latagliata R, Halkes CJ, Falzetti F, Magro D, Guimaraes JE, Berneman Z, Specchia G, Karrasch M, Fazi P, Vignetti M, Willemze R, de Witte T, Marie JP. Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14. PMID 24127442