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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739388
• Other study ID #: SAKK 30/07
• Secondary ID: SWS-SAKK-30/07CD
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: April 9, 2013
• Start date: July 2008
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Inselspital Bern	Bern
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

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Passweg JR, Pabst T, Blum S, Bargetzi M, Li Q, Heim D, Stussi G, Gregor M, Leoncini L, Meyer-Monard S, Brauchli P, Chalandon Y; Swiss Group for Clinical Cancer Research (SAKK). Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best response (complete or partial response)		within 6 months	No
Secondary	Time to response		is defined as the time from trial registration until the date the criteria for either CR or PR are first met	No
Secondary	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.	No
Secondary	Best response status		within 6 months	No
Secondary	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.	No
Secondary	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.	No
Secondary	Event-free survival		is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.	No
Secondary	Overall survival		is defined as the time from trial registration until death from any cause.	No
Secondary	Adverse events according to NCI CTCAE v3.0		according to NCI CTCAE v3.0	Yes
Secondary	Adjusted hospitalization time		is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).	No