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

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Azacitidine; Drug: DA

• Registration Number: NCT01794169
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-18
• Study Start: 2013-03
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Leukemia free survival	One year

Secondary Outcome Measures

Name	Time	Method
Treatment related morbidity and mortality	Two years
Overall survival	Two years
Severe Adverse Events (SAE)	Two months after the last course of consolidation	SAE as defined by CTCAE
Number of participants with AE grade 3 or more	Until two months after the last course of consolidation	AE:s graded according to CTCAE
Number of days admitted in hospital	12 months from start of consolidation treatment
Number of consolidation courses actually given within the study	One year
Quality of life	Until 24 months from start of consolidation treatment	EORTC QLQ C30

Trial Locations

Locations (1)

Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden