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

NCT ID: NCT01794169

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacitidine

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

Group Type: EXPERIMENTAL

Azacitidine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

DA

Intervention Type: DRUG

Interventions

Azacitidine

Intervention Type: DRUG

DA

Intervention Type: DRUG

Other Intervention Names

Vidaza; Daunorubicin; Cytarabine; Ara-C

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stefan Deneberg

M.D, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Bernell, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Stefan Deneberg, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital, Solna

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

SWEAML12-a

Identifier Type: -

Identifier Source: org_study_id