Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Secondary

* To assess the incidence of clinical remission/complete remission or partial response in these patients.
* To assess hematological improvement in patients treated with this drug.
* To assess the overall survival of patients treated with this drug.
* To assess progression-free survival of patients treated with this drug.
* To assess the time to acute myeloid leukemia (AML) transformation of CMML.
* To assess the time to death or AML transformation of CMML.
* To assess the biological correlates.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5 and 8-9. Treatment repeats every 4 weeks for at least 6 courses in the absence of loss of response/disease progression or unacceptable toxicity. Patients undergo response evaluation after 6 courses or the last course of treatment. Responders may continue azacitidine until loss of response/disease progression or unacceptable toxicity.

Some patients undergo blood, bone marrow, and buccal swab sample collection periodically for correlative studies.

After completion of study treatment, patients are followed up for 1 month.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Conditions

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Leukemia

Keywords

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chronic myelomonocytic leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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azacitidine

Intervention Type DRUG

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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David T. Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

Leeds Cancer Centre at St. James's University Hospital

Locations

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Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom