Clinical trial NCT01794169: Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML
Official title: Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2013-02-18
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Leukemia free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: Two years
measure: Treatment related morbidity and mortality
timeFrame: Two years
measure: Severe Adverse Events (SAE)
timeFrame: Two months after the last course of consolidation
measure: Number of days admitted in hospital
timeFrame: 12 months from start of consolidation treatment
measure: Quality of life
timeFrame: Until 24 months from start of consolidation treatment
measure: Number of participants with AE grade 3 or more
timeFrame: Until two months after the last course of consolidation
measure: Number of consolidation courses actually given within the study
timeFrame: One year
Other outcomes:
measure: Molecular analyses
timeFrame: Two years
measure: Leukemia free survival (LFS)
timeFrame: One year
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
Study officials:
affiliation: Karolinska University Hospital
name: Per Bernell, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Stefan Deneberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: