Acute Myeloid Leukemia
Conditions
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.
Interventions
DRUGAzacitidine
DRUGDA
Sponsors
Celgene Corporation
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects \>65 years of age at the time of signing the informed consent form 2. 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). 3. A documented CR or CRp achieved after one or two induction courses.
Exclusion criteria
1. Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons. 2. Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening. 3. Patients with acute promyelocytic leukemia 4. Patients with t(8;21) or inv(16) 5. CNS leukemia 6. Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS 7. Subjects who are candidates for allogeneic stem cell transplantation (SCT) 8. Another cancer diagnosis with a life expectancy of less than two years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leukemia free survival | One year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Until 24 months from start of consolidation treatment | EORTC QLQ C30 |
| Number of participants with AE grade 3 or more | Until two months after the last course of consolidation | AE:s graded according to CTCAE |
| Number of consolidation courses actually given within the study | One year | — |
| Overall survival | Two years | — |
| Severe Adverse Events (SAE) | Two months after the last course of consolidation | SAE as defined by CTCAE |
| Number of days admitted in hospital | 12 months from start of consolidation treatment | — |
| Treatment related morbidity and mortality | Two years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Molecular analyses | Two years | Analysis of a broad spectrum of molecular and cellular events relating to the epigenetic status of the malignant cells. These events will be used to identify biomarkers for successful consolidation and to address whether AML cases that relapse while on the study are molecularly and epigenetically different between those given azacitidine or DA consolidation |
| Leukemia free survival (LFS) | One year | Analysis whether cytogenetic and molecular aberrations at diagnosis will predict for better LFS with either Azacitidine or standard DA consolidation. |
Countries
Sweden
Outcome results
None listed