Azacitidine compared to conventional chemotherapy in consolidation of elderly patients (> 65 years) with acute leukemia after the first complete response

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10024348Term: Leukemia myelogenousSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10024307Term: Leukaemia myelogenousSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000981-40-SE
• Lead Sponsor: The Swedish AML Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-20
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 CEBPA
• Biobanking 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.
• CR is defined as
-bone marrow blasts < 5% with regenerating hematopoiesis
-no extramedullary leukemia
-independency of erythrocyte transfusions
-neutrophils > 1.0 x 10(9)/L
-platelets > 100 x 10(9)/L

• Criteria for complete remission with low platelet count (CRp):
- A patient fulfilling bone marrow and peripheral blood criteria for CR in AML but who has a lower platelet count than 100 x 10(9) may also be considered CR (CRp) provided platelet count is stable and greater than 30 x 10(9) and there is no bleeding symptoms.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 130

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 preceeded by a diagnosed MDS
7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)
8. Another cancer diagnosis with a life expecancy of less than two years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate whether consolidation treatment with repeated courses of azacitidine prolongs leukemia–free survival (LFS) as compared to standard consolidation chemotherapy in elderly (=65y) patients with AML in CR1. ;Secondary Objective: Study whether consolidation treatment with azacytidine, as compared with the control arm,<br>improves overall survival (OS)<br><br>- Assess the relationship between azacitidine treatment and DNA-methylation patterns<br>- Assess the clinical outcome according to molecular mutations and cytogenetic aberrancies at diagnosis<br>- Assess safety, tolerability of azacitidine when given after standard induction chemotherapy (DA) in elderly patients with AML<br>- Assess quality of life in patients receiving consolidation with azacitidin and standard chemotherapy, repsectively<br>;Primary end point(s): LFS at 12 months after start of induction chemotherapy (DA)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - OS 2 years after start of induction chemotherapy (DA)<br>- 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<br>- Treatment related morbidity and mortality<br>- SAE until two months after the last course of consolidation <br>- No of consolidation courses actually given.<br>- No of days in hospital during the period of 12 months from start of consolidation treatment as well as quality of life during and after consolidation.<br><br>