A phase II study of 5-azacitidine in chronic myelomonocytic leukaemia (CMML)

Phase 2

Completed

• Conditions: Chronic myelomonocytic leukaemia; Cancer; Myeloid leukaemia

• Registration Number: ISRCTN21428905
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24569776 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-18
• Study Completion: 2013-05-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with newly diagnosed or previously treated CMML-1 or CMML-2 according to World Health Organization (WHO) criteria (2008)
2. Subject is able and willing to sign the informed consent form
3. Age 18 years or over, either sex, at the time of signing the informed consent form
4. WHO performance status of less than or equal to 2 at study entry
5. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to start of study drug
6. WCBP and men with WCBP partners must agree to use adequate contraceptive methods while on study drug and 6 months after the end of the study

Exclusion Criteria

1. CMML with eosinophilia and 5q33 abnormality
2. Previous chemotherapy for CMML except hydroxycarbamide
3. Creatinine concentration more than 1.5 x the institutional upper limit of the normal range
4. Pregnant or lactating females
5. Use of any other experimental drug or therapy within 28 days of baseline
6. Known hypersensitivity to azacitidine
7. Other active malignant disease
8. Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B or C
9. Active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified