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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01794169
• Other study ID #: SWEAML12-a
• Status: Terminated
• Phase: Phase 2
• First received: February 13, 2013
• Last updated: September 19, 2015
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: September 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: March 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Azacitidine

• DA

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Solna	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Celgene Corporation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Molecular analyses	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	Two years	No
Other	Leukemia free survival (LFS)	Analysis whether cytogenetic and molecular aberrations at diagnosis will predict for better LFS with either Azacitidine or standard DA consolidation.	One year	No
Primary	Leukemia free survival		One year	No
Secondary	Overall survival		Two years	No
Secondary	Treatment related morbidity and mortality		Two years	Yes
Secondary	Severe Adverse Events (SAE)	SAE as defined by CTCAE	Two months after the last course of consolidation	Yes
Secondary	Number of days admitted in hospital		12 months from start of consolidation treatment	No
Secondary	Quality of life	EORTC QLQ C30	Until 24 months from start of consolidation treatment	No
Secondary	Number of participants with AE grade 3 or more	AE:s graded according to CTCAE	Until two months after the last course of consolidation	Yes
Secondary	Number of consolidation courses actually given within the study		One year	No