Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01235117
Protocol/serial number
HM08/8540
Study information
Scientific title
5-azacitidine in chronic myelomonocytic leukaemia (CMML): a two stage phase II, non-randomised, single arm, multi-centre, prospective trial
Acronym
CMML201
Study hypothesis
To assess the safety, tolerability and efficacy of 5-azacitidine in patients with chronic myelomonocytic leukaemia (CMML).
Please note as of 04/11/2009 this record was updated to include extensions to the anticipated start and end dates; the initial trials dates at the time of registration were:
Initial anticipated start date: 15/03/2009
Initial anticipated end date: 15/03/2011
05/03/2013: Please note that as of 17/08/2010, recruitment for this trial closed
Ethics approval
Added 04/11/2009:
Northern and Yorkshire Research Ethics Committee on 28/04/2009 (ref: 09/H0903/13)
Amendment 1 on 02/09/2009
Study design
Two stage phase II non-randomised single arm multi-centre prospective trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic myelomonocytic leukaemia
Intervention
Patients should be assessed for their suitability for treatment on Day -5 to Day 1 (start of treatment) of each cycle. Patients should be pre-medicated with ondansentron as per local anti-emetic policy. All patients will receive 100 mg/m^2 of 5-azacitidine on days 1 - 5 by subcutaneous injection. Those patients unable to tolerate the subcutaneous route of drug administration (due to severe local skin reactions) will be withdrawn from the study.
The cycle is repeated every 28 days for at least 6 cycles or until disease progression. After the 6th cycle of treatment all patients will undergo an assessment of response; responders may continue drug administration until loss of response or development of unacceptable toxicity.
Intervention type
Drug
Phase
Phase II
Drug names
5-azacitidine, ondansentron
Primary outcome measure
1. To assess the safety and tolerability of 5-azacitidine, monitored throughout the trial
2. To assess the overall response rate, measured at the end of treatment
Secondary outcome measures
To assess response of disease to 5-azacitidine, specifically:
1. Incidence of complete remission (CR)/partial remission(PR)
2. Haematological improvement
3. Control of myeloproliferation
4. Incidence of reduction in spleen size by greater than 50%
5. Overall survival
6. Time to acute myeloid leukaemia (AML) transformation of CMML
7. Time to death or AML transformation of CMML
8. Biological correlates
All monitored throughout the trial.
Overall trial start date
23/11/2009
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
23/11/2009
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bexley Wing 3rd Floor
Leeds
LS9 7DF
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust (UK)
Sponsor details
c/o Dr Derek Norfolk
Associate Director of R&D
Department of Research & Development
A/B Floor
Old Site Worsley Building
Leeds General Infirmary
Great George Street
Leeds
LS9 6LN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Celgene Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24569776