NCT01794169

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

February 13, 2013

Last Update Submit

September 19, 2015

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Leukemia free survival

    One year

Secondary Outcomes (7)

  • Overall survival

    Two years

  • Treatment related morbidity and mortality

    Two years

  • Severe Adverse Events (SAE)

    Two months after the last course of consolidation

  • Number of days admitted in hospital

    12 months from start of consolidation treatment

  • Quality of life

    Until 24 months from start of consolidation treatment

  • +2 more secondary outcomes

Other Outcomes (2)

  • Molecular analyses

    Two years

  • Leukemia free survival (LFS)

    One year

Study Arms (2)

Azacitidine

EXPERIMENTAL

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

Drug: Azacitidine

DA

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.

Drug: DA

Interventions

AzacitidineDRUG
Also known as: Vidaza
Azacitidine
DADRUG
Also known as: Daunorubicin, Cytarabine, Ara-C
DA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Solna

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

AzacitidineDaunorubicinCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesArabinonucleosides

Study Officials

  • Per Bernell, M.D., Ph.D.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

  • Stefan Deneberg, M.D., Ph.D.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D.

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 18, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

March 1, 2018

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

SE(1)