Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

Phase 2

Completed

• Conditions: Leukemia
• Interventions: Drug: azacytidine

• Registration Number: NCT00739388
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the efficacy of azacitidine in patients with newly diagnosed or untreated acute myeloid leukemia who are unsuitable for induction type chemotherapy because of age or relevant comorbidities.

Secondary

* To evaluate survival and adverse events.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Primary Completion: 2010-01
• Study Completion: 2012-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm: 5-azacytidine	azacytidine	5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Best response (complete or partial response)	within 6 months

Secondary Outcome Measures

Name	Time	Method
Best response status	within 6 months
Overall survival	is defined as the time from trial registration until death from any cause.
Adverse events according to NCI CTCAE v3.0	according to NCI CTCAE v3.0
Time to response	is defined as the time from trial registration until the date the criteria for either CR or PR are first met
Event-free survival	is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.
Time to hematological improvement (HI)	is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.
Duration of HI	is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.
Response duration	is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.
Adjusted hospitalization time	is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).

Trial Locations

Locations (11)

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital, Luzerne; 🇨🇭 Luzerne, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Hopitaux Universitaires de Geneve; 🇨🇭 Thonex-Geneve, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland