Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

NCT01235117 | Completed Phase 2

• 6 other identifiers: CDR0000688119CTRU-CMML-201ISRCTN-21428905EUDRACT-2008-006349-23LEEDS-HM08/8540EU-21082
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Leukemia

Keywords

chronic myelomonocytic leukemia

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability

• Overall response rate

Secondary Outcomes (7)

• Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria

• Hematological improvement according to IWG criteria

• Overall survival

• Progression-free survival

• Time to acute myeloid leukemia (AML) transformation of CMML

Interventions

azacitidine DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (2)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myelomonocytic, Chronic

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David T. Bowen, MD

  Leeds Cancer Centre at St. James's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2010-11

Locations

GB (2)