Overview

Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML

Status:
Terminated

Trial end date:
2018-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Karolinska University Hospital

Collaborator:

Celgene Corporation

Treatments:

Azacitidine
Cytarabine
Daunorubicin

Criteria

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