Trial Profile
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg) Induction Therapy Versus Standard Induction With Daunomycin [daunorubicin] and Cytosine Arabinoside [cytarabine] Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg) or No Additional Therapy For Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML).
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 21 Apr 2023
Price :
$35
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At a glance
- Drugs Gemtuzumab ozogamicin (Primary) ; Cytarabine; Daunorubicin
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms GAIN
- 04 Dec 2018 Results evaluating event-free survival (EFS) as a surrogate endpoint for OS in untreated AML from 4 multicenter, randomized controlled phase III trials (n=2475), NCT00085124, NCT00651261,NCT00085709, NCT00049517, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
- 04 Mar 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
- 24 Aug 2012 Planned end date changed from 1 Mar 2010 to 1 Aug 2014 as reported by ClinicalTrials.gov record