Status:
TERMINATED
Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Celgene Corporation
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients...
Eligibility Criteria
Inclusion
- Subjects \>65 years of age at the time of signing the informed consent form
- A confirmed diagnosis of AML according to the 2008 WHO classification
- This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A
- Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).
- A documented CR or CRp achieved after one or two induction courses.
Exclusion
- Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
- Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
- Patients with acute promyelocytic leukemia
- Patients with t(8;21) or inv(16)
- CNS leukemia
- Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS
- Subjects who are candidates for allogeneic stem cell transplantation (SCT)
- Another cancer diagnosis with a life expectancy of less than two years
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01794169
Start Date
March 1 2013
End Date
March 1 2018
Last Update
September 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska University Hospital, Solna
Stockholm, Sweden, 17176