Leukemia
Conditions
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7)
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.
Interventions
DRUGazacytidine
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
Sponsors
Swiss Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best response (complete or partial response) | within 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| Time to response | is defined as the time from trial registration until the date the criteria for either CR or PR are first met |
| 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). |
| Event-free survival | is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first. |
Countries
Switzerland
Outcome results
None listed