Status:
COMPLETED
Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
Lead Sponsor:
University of Leeds
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pha...
Detailed Description
OBJECTIVES: Primary * To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML). * To assess the overall response rate in these patients. Secondar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01235117
Start Date
January 1 2010
End Date
May 1 2013
Last Update
August 26 2013
Active Locations (2)
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1
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
2
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN