A phase II study of 5-azacitidine in chronic myelomonocytic leukaemia (CMML)
| ISRCTN | ISRCTN21428905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21428905 |
| ClinicalTrials.gov number | NCT01235117 |
| Secondary identifying numbers | HM08/8540 |
- Submission date
- 26/11/2008
- Registration date
- 18/12/2008
- Last edited
- 29/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof David Bowen
Scientific
Scientific
Bexley Wing 3rd Floor
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7DF
United Kingdom
Study information
| Study design | Two stage phase II non-randomised single arm multi-centre prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 5-azacitidine in chronic myelomonocytic leukaemia (CMML): a two stage phase II, non-randomised, single arm, multi-centre, prospective trial |
| Study acronym | CMML201 |
| Study objectives | 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(s) | Added 04/11/2009: Northern and Yorkshire Research Ethics Committee on 28/04/2009 (ref: 09/H0903/13) Amendment 1 on 02/09/2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 23/11/2009 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/11/2009 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bexley Wing 3rd Floor
Leeds
LS9 7DF
United Kingdom
LS9 7DF
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
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
England
United Kingdom
| Website | http://www.leedsth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00v4dac24 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Celgene Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No | |
| Plain English results | 14/08/2014 | 29/03/2022 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
23/06/2016: Publication reference added
