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

NCT ID: NCT00739388

Last Updated: 2013-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm: 5-azacytidine

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

Group Type: EXPERIMENTAL

azacytidine

Intervention Type: DRUG

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

Interventions

azacytidine

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

Intervention Type: DRUG

Other Intervention Names

Azacitidine; 5-azacytidine; Vidaza

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jakob Passweg, Prof

Role: STUDY_CHAIR

Hopitaux Universitaires de Geneve

Sabine Blum, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Locations

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

Sankt Gallen, , Switzerland

Hopitaux Universitaires de Geneve

Thonex-Geneve, , Switzerland

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Countries

Switzerland

References

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 II trial (SAKK 30/07). Leuk Lymphoma. 2014 Jan;55(1):87-91. doi: 10.3109/10428194.2013.790540. Epub 2013 May 2.

Reference Type: RESULT

PMID: 23547838 (View on PubMed)

Other Identifiers

SWS-SAKK-30/07

Identifier Type: -

Identifier Source: secondary_id

CDR0000612029

Identifier Type: -

Identifier Source: secondary_id

SAKK 30/07

Identifier Type: -

Identifier Source: org_study_id