Safety, compliance with and activity of Bezafibrate and medroxyProgesterone acetate (BaP) as non-toxic therapy against myeloid and lymphoid cancers
- Conditions
- Acute Myeloblastic Leukaemia or high risk myelodysplasia (RAEB2 WHO criteria) (AML), B cell Chronic Lymphocytic Leukaemia (CLL) and B cell Non Hodgkins Lymphoma (BNHL)CancerAcute myeloid leukaemia
- Registration Number
- ISRCTN99131400
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31011660 results (added 10/12/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety: The number of grade 3 and 4 Adverse Reactions and Serious Adverse Reactions (SARs) attributable to the trial drugs<br>2. Patient compliance: Percentage of allocated treatment taken <br>3. Activity: <br>3.1. Haematological Response in the first 18 weeks of treatment<br>3.2. Clinical Response in the first 18 weeks of treatment
- Secondary Outcome Measures
Name Time Method Quality of life questionnaires:<br>1. EQ-5D<br>2. EORTC QLQ-C30 <br><br>Measured at baseline, between week 7-11 and at the final assessment at week 18