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

Sponsor
Karolinska University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01794169
Collaborator
Celgene Corporation (Industry)
130
Enrollment
1
Location
2
Arms
60
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azacitidine

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

Drug: Azacitidine
Other Names:
  • Vidaza

    		•
    Active Comparator: DA

    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
    Other Names:
  • Daunorubicin
  • Cytarabine
  • Ara-C

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Leukemia free survival [One year]

    Secondary Outcome Measures

    1. Overall survival [Two years]

    2. Treatment related morbidity and mortality [Two years]

    3. Severe Adverse Events (SAE) [Two months after the last course of consolidation]

      SAE as defined by CTCAE

    4. Number of days admitted in hospital [12 months from start of consolidation treatment]

    5. Quality of life [Until 24 months from start of consolidation treatment]

      EORTC QLQ C30

    6. Number of participants with AE grade 3 or more [Until two months after the last course of consolidation]

      AE:s graded according to CTCAE

    7. Number of consolidation courses actually given within the study [One year]

    Other Outcome Measures

    1. Molecular analyses [Two years]

      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

    2. Leukemia free survival (LFS) [One year]

      Analysis whether cytogenetic and molecular aberrations at diagnosis will predict for better LFS with either Azacitidine or standard DA consolidation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska University Hospital, Solna Stockholm Sweden 17176

    Sponsors and Collaborators

    • Karolinska University Hospital
    • Celgene Corporation

    Investigators

    • Principal Investigator: Per Bernell, M.D., Ph.D., Karolinska University Hospital
    • Principal Investigator: Stefan Deneberg, M.D., Ph.D., Karolinska University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Deneberg, M.D, Ph.D., Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT01794169
    Other Study ID Numbers:
    • SWEAML12-a
    First Posted:
    Feb 18, 2013
    Last Update Posted:
    Sep 22, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Cytarabine
    Azacitidine
    Daunorubicin

    Study Results

    No Results Posted as of Sep 22, 2015