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.
- Conditions
- Previously untreated primary or secondary AML (including AML after MDS).All FAB subtypes except M3.No AML supervening after other myeloproliferative diseases.Age 61-75 years.MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-001347-37-IT
- Lead Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method