Suspended

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

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What is being tested

Azacitidine

+ DA

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

Over 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorKarolinska University Hospital
Last updated: September 22, 2015
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Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01794169
Principal SponsorKarolinska University Hospital
Last updated: September 22, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Karolinska University Hospital, Solna

Stockholm, SwedenOpen Karolinska University Hospital, Solna in Google Maps
SuspendedOne Study Center