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

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00739388

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: azacytidine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm: 5-azacytidine 5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.	Drug: azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle Other Names: Azacitidine 5-azacytidine Vidaza

Arm

Intervention/Treatment

Experimental: Arm: 5-azacytidine

5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.

Drug: azacytidine

100 mg/m2/day s.c. on days 1-5 of a 28-day cycle

Other Names:

Azacitidine

5-azacytidine

Vidaza

Outcome Measures

Primary Outcome Measures

Best response (complete or partial response) [within 6 months]

Secondary Outcome Measures

Time to response [is defined as the time from trial registration until the date the criteria for either CR or PR are first met]
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.]
Best response status [within 6 months]
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.]
Event-free survival [is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.]
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]
Adjusted hospitalization time [is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
De novo acute myeloid leukemia (AML)
AML secondary to prior hematological disease or cytotoxic treatment
Newly diagnosed or untreated disease
At least 20% blasts in the blood or bone marrow or extramedullary disease
Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:
High age or frail for the biologic age
Relevant comorbidities
Unwilling to undergo intensive chemotherapy
No chronic myelogenous leukemia or acute promyelocytic leukemia

PATIENT CHARACTERISTICS:

WHO performance status 0-3
Bilirubin ≤ 3 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
AST ≤ 2.5 times ULN
Serum creatinine ≤ 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
Patient compliance and geographic proximity allow proper staging and follow-up
No NYHA class III-IV heart failure or relevant cardiac arrhythmia
No active hematological/oncological disease other than AML
No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:
Active autoimmune disease
Uncontrolled diabetes
Active uncontrolled infection
HIV infection
Active chronic hepatitis B or C infection
No known allergy or hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

No prior treatment for AML
No prior azacitidine or decitabine
No other concurrent experimental or investigational drugs or anticancer therapy
More than 30 days since participation in another clinical trial
No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kantonspital Aarau	Aarau	Switzerland	CH-5001
2	Kantonsspital Baden	Baden	Switzerland	CH-5404
3	Universitaetsspital-Basel	Basel	Switzerland	CH-4031
4	Oncology Institute of Southern Switzerland	Bellinzona	Switzerland	CH-6500
5	Inselspital Bern	Bern	Switzerland	CH-3010
6	Spitalzentrum Biel	Biel	Switzerland	CH-2500
7	Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	CH-1011
8	Kantonsspital, Luzerne	Luzerne	Switzerland	CH-6000
9	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007
10	Hopitaux Universitaires de Geneve	Thonex-Geneve	Switzerland	CH-1226
11	UniversitaetsSpital Zuerich	Zurich	Switzerland	CH-8091