Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Azacitidine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• All chronic myelomonocytic leukemia (CMML)-2 patients

• CMML-1 patients meeting any of the following criteria:

• Symptomatic bone marrow failure/myeloproliferation defined as any of the following:

• Red cell transfusion dependence and pre-transfusion hemoglobin < 9.0 g/dL

• Symptomatic anemia (hemoglobin < 11.5 g/dL)

• Thrombocytopenia (platelet count < 50 x 10^9/L)

• Symptomatic bleeding due to platelet functional defect or disseminated intravascular coagulation (DIC)/fibrinolysis

• White cell count (WCC) > 50 x 10^9/L

• Düsseldorf Score of intermediate or high risk for proliferative CMML-1 (i.e., WCC > 12 x 10^9/L)

• International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk for non-proliferative CMML-1 (i.e., WCC < 12 x 10^9/L)

• Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within the past 6 months)

• Symptomatic splenomegaly

• Symptomatic extramedullary involvement (e.g. skin infiltration or serous effusions)

• No CMML with eosinophilia and 5q33 abnormality

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Creatinine ≤ 2 times upper limit of normal

• Not pregnant or nursing

• Negative urine pregnancy test

• Fertile patients must use at least 2 forms of effective contraception during study and for 3 months after completion of study therapy

• No other active malignant disease including basal cell or squamous cell carcinoma of the skin

• No known HIV or infectious hepatitis B or hepatitis C

• No active infection

• No known hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

• At least 28 days since other prior experimental drug or therapy

• No prior chemotherapy for this disease except hydroxycarbamide

• No other concurrent anticancer or investigational agents