Condition category
Cancer
Date applied
16/09/2011
Date assigned
25/10/2011
Last edited
11/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Mark Drayson

ORCID ID

Contact details

School of Immunity and Infection
The Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG_11-054

Study information

Scientific title

Single arm phase II trial assessing the safety, compliance with and activity of Bezafibrate and medroxyProgesterone acetate (BaP) as non-toxic therapy against myeloid and lymphoid cancers

Acronym

BaP

Study hypothesis

To test in patients with acute myeloblastic leukaemia (AML) or high risk myelodysplasia (RAEB2 WHO criteria), B cell Chronic Lymphocytic Leukaemia (CLL) and B cell Non Hodgkins Lymphoma (BNHL) the following outcomes of BaP administration over 18 weeks:
1. Safety
2. Compliance (feasibility of delivery)
3. Anti-cancer activity

Ethics approval

NRES Committee East Midlands - Nottingham 2, 13/11/2012, ref: 11/EM/0426

Study design

Phase II single arm four centre pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute Myeloblastic Leukaemia or high risk myelodysplasia (RAEB2 WHO criteria) (AML), B cell Chronic Lymphocytic Leukaemia (CLL) and B cell Non Hodgkins Lymphoma (BNHL)

Intervention

All patients will receive BaP. BaP is Bezafibrate at 6 x 400 mg twice daily and medroxyProgesterone acetate at 5 x 200 mg daily. Patients will commence BaP at registration and continue for 18 weeks where the primary endpoint will be assessed. Patient may continue beyond 18 weeks at the discretion of the treating clinician.

Intervention type

Drug

Phase

Phase II

Drug names

Bezafibrate, Medroxyprogesterone acetate

Primary outcome measures

1. Safety: The number of grade 3 and 4 Adverse Reactions and Serious Adverse Reactions (SARs) attributable to the trial drugs
2. Patient compliance: Percentage of allocated treatment taken
3. Activity:
3.1. Haematological Response in the first 18 weeks of treatment
3.2. Clinical Response in the first 18 weeks of treatment

Secondary outcome measures

Quality of life questionnaires:
1. EQ-5D
2. EORTC QLQ-C30

Measured at baseline, between week 7-11 and at the final assessment at week 18

Overall trial start date

01/12/2011

Overall trial end date

10/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with one of the following diagnoses:
1.1. AML or high risk myelodysplasia (RAEB-2 WHO criteria)
1.2. CLL
1.3. BNHL
2. Be 18 years or older
3. Have given written informed consent

For AML and MDS
1. Haemopoiesis must be impaired by the disease as judged by an abnormal full blood count (FBC) (International Working Group response criteria in myelodysplasia) and, where there is doubt as to the cause of impaired haemopoiesis, there must be bone marrow aspirate evidence that impaired haemopoiesis is due to cancer involvement of the bone marrow.
2. Abnormal values are haemoglobin level less than 11 g/dL or red blood cells (RBC) transfusion dependence, platelet count less than 100 x 109/L or platelet-transfusion dependence, absolute neutrophil count less than 1.0x 109/L. Pretreatment baseline measures of cytopenias are averages of at least two measurements (not influenced by transfusions, i.e. no RBC transfusions for at least 1 week and no platelet transfusions for at least 3 days) over at least 1 week prior to therapy.

For CLL and BNHL
1. Patients must have either measurable disease (tumour cells in blood at >5 x 109/L, or lymphadenopathy > 1cm) or bone marrow failure due to disease as stated above for MDS / AML.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patient considered suitable for other forms of anti-cancer therapy (either accepted standard therapy or therapy in the context of a clinical trial) other than palliative corticosteroids or hydroxyurea
2. Estimated Glomerular Filtration Rate (eGFR) < 30ml/min
3. Patient known to be allergic to trial drugs
4. Patient has received treatment with any investigational medicinal product within the previous 28 days
5. Patient unable to swallow orally administered medications
6. Patient has uncontrolled seizures
7. Patient has active infection requiring systemic antibiotics, antifungal or antiviral drugs
8. Patient has concurrent severe and/or uncontrolled medical condition [e.g. severe chronic obstructive pulmonary disorder (COPD), severe Parkinsons’s disease] or psychiatric condition
9. Women of child-bearing potential and men who have partners of child-bearing potential who are not willing to practise effective contraception for the duration of the study and for three months after the last study drug administration
10. Pregnant or lactating women. Women of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration.

Recruitment start date

01/10/2012

Recruitment end date

01/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Stadium Rd
London
SE18 4QH
United Kingdom

Trial participating centre

Heartlands Hospital
Bordesley Green E
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Good Hope Hospital
Rectory Rd
Sutton Coldfield
B75 7RR
United Kingdom

Trial participating centre

Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Trial participating centre

New Cross Hospital
Wednesfield Rd
WV10 0QP
WV10 0QP
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research Support Group
Institute of Research and Development
Birmingham Research Park
Vincent Drive
Edgbaston
Birmingham
B15 2SQ
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Charity

Funder name

Queen Elizabeth Hospital Charity (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

Publication citations

Additional files

Editorial Notes

11/05/2016: Internal review 06/05/2016: Verified study information with principal investigator. Changed overall study end date from 01/12/2013 to 10/09/2014. Chanrged recruitment date period from 01/12/2011-01/12/2013 to 01/10/2012-01/07/2014. Added trial participating centres and ethics approval information 26/04/2016: No publications found, verifying study status with principal investigator