Condition category
Cancer
Date applied
26/11/2008
Date assigned
18/12/2008
Last edited
23/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof David Bowen

ORCID ID

Contact details

Bexley Wing 3rd Floor
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7DF
United Kingdom

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patients unable to tolerate the subcutaneous route of drug administration (due to severe local skin reactions) will be withdrawn from the study.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 measures

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

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

http://www.leedsth.nhs.uk/

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

23/06/2016: Publication reference added