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
Phase 1
- Conditions
- Elderly patients (61-75 years not eligible for intensive chemotherapyage > 75 years), with previously untreated, primary or secondary (no after other myeloproliferative diseases) AML (except M3).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
- EUCTR2004-004356-39-IT
- Lead Sponsor
- E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 259
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 Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method