Clinical trial · Interventional
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Gemtuzumab Ozogamicin (GO) Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy: A Randomized Phase II/III Trial (AML-19) of the EORTC-LG and GIMEMA-ALWP
NCT00091234CI-TRIAL-00007534AML-19unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive care in treating older patients who have acute myeloid leukemia. PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of patients able to start continuation therapy (Phase II)
- measure
- Overall survival (Phase III)
Secondary outcomes (6)
- measure
- Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)
- measure
- Overall survival (Phase II)
- measure
- Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)
- measure
- Rate of complete remisison (CR+CRp) by the end of induction and by the end of continuation therapy, for patients in GO arm (Phase III)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * At least 20% bone marrow blasts by bone marrow aspiration or biopsy * All subtypes except M3 (acute promyelocytic leukemia) are allowed * Previously untreated primary or secondary disease (including AML after myelodysplastic syndromes) * Ineligible for intensive chemotherapy, as defined by 1 of the following criteria: * 61 to 75 years old AND WHO performance status \> 2 AND/OR unwilling to receive intensive chemotherapy * Over 75 years old * No blast crisis of chronic myeloid leukemia * No AML supervention after other myeloproliferative disease * WBC \< 30,000/mm\^3 and meets 1 of the following criteria: * WBC \< 30,000/mm\^3 at diagnosis AND had no prior treatment with hydroxyurea * WBC ≥ 30,000/mm\^3 at diagnosis AND received mandatory pretreatment with hydroxyurea (up to 14 days duration) until WBC \< 30,000/mm\^3 * No active CNS leukemia PATIENT CHARACTERISTICS: Age * See Disease Characteristics * 61 and over Performance status * See Disease Characteristics Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No arrhythmia requiring chronic treatment * No congestive heart failure * No symptomatic ischemic heart disease * No other severe cardiovascular disease Pulmonary * No severe pulmonary dysfunction ≥ grade 3 Other * No alcohol abuse * No severe neurological or psychiatric disease * No active uncontrolled infection or severe systemic infection * No other malignancy * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent antiangiogenic drugs Chemotherapy * See Disease Characteristics * Concurrent low-dose cytostatic agents (i.e., thioguanine or mercaptopurine) allowed for palliative care (standard supportive care arm only) Endocrine therapy * Prior corticosteroids (duration ≤ 14 days ) for primary or secondary AML allowed Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent cytotoxic drugs * No other concurrent experimental therapy * No concurrent tyrosine kinase inhibitors
References
Publications (2)
- RESULTAmadori S, Suciu S, Selleslag D, et al.: Phase II-III study of gemtuzumab ozogamicin monotherapy versus best supportive care in older patients with newly diagnosed AML unfit for intensive chemotherapy: first results of the EORTC-GIMEMA AML-19 trial. [Abstract] Blood 112 (11): A-762, 2008.
- DERIVEDAmadori S, Suciu S, Selleslag D, Aversa F, Gaidano G, Musso M, Annino L, Venditti A, Voso MT, Mazzone C, Magro D, De Fabritiis P, Muus P, Alimena G, Mancini M, Hagemeijer A, Paoloni F, Vignetti M, Fazi P, Meert L, Ramadan SM, Willemze R, de Witte T, Baron F. Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncol. 2016 Mar 20;34(9):972-9. doi: 10.1200/JCO.2015.64.0060. Epub 2016 Jan 25. PMID 26811524