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

Study Overview
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Brief Summary
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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.

Official Title
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Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Azacitidine
* Drug: DA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azacitidine<br>Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles. | Drug: Azacitidine<br> <br> * Other names: Vidaza;|
| Active Comparator: DA<br>Two courses of DA in accordance with the Swedish National treatment program (reduced doses): In case one induction course was given: First consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4. Second consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. In case two induction courses were given: First consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. Second consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5. | Drug: DA<br> <br> * Other names: Ara-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukemia free survival |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Two years | 
| Treatment related morbidity and mortality |  | Two years | 
| Severe Adverse Events (SAE) | SAE as defined by CTCAE | Two months after the last course of consolidation | 
| Number of days admitted in hospital |  | 12 months from start of consolidation treatment | 
| Quality of life | EORTC QLQ C30 | Until 24 months from start of consolidation treatment | 
| Number of participants with AE grade 3 or more | AE:s graded according to CTCAE | Until two months after the last course of consolidation | 
| Number of consolidation courses actually given within the study |  | One year |