A trial to assess the safety, feasibility and effectiveness of two drugs, Bezafibrate and medroxyProgesterone acetate (BaP) as non-toxic therapy against Acute Myeloblastic Leukaemia or high risk myelodysplasia (AML), B cell Chronic Lymphocytic Leukaemia (CLL) and B cell Non Hodgkins Lymphoma (BNHL).
- Conditions
- Acute Myeloid Leukaemia (AML), Chronic Lymphocytic Leukaemia (CLL) and B-cell Non-Hodgkins Lymphoma (BNHL)MedDRA version: 14.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001955-35-GB
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Patients must:
ohave one of the following diagnoses:
-AML or high risk myelodysplasia (RAEB2 WHO criteria)
-CLL
-BNHL
obe 18 years or older
ohave given written informed consent
For AML and RAEB-2
•Haemopoiesis must be impaired by the disease as judged by an abnormal FBC (International Working Group response criteria in myelodysplasia [2]) 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.
•Abnormal values are haemoglobin level less than 11 g/dL or 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 2 measurements (not influenced by transfusions, ie, 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
•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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
• 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
• Patient has eGFR<40ml/min
• Patient known to be allergic to trial drugs
• Patient has received treatment with any investigational medicinal product within the previous 28 days
• Patient unable to swallow orally administered medications
• Patient has uncontrolled seizures
• Patient has active infection requiring systemic antibiotics, antifungal or antiviral drugs
• Patient has concurrent severe and/or uncontrolled medical condition (e.g. severe COPD, severe Parkinsons’s disease) or psychiatric condition
• 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
• Pregnant or lactating women. Pre-menopausal 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The principal research question of this study is to determine if BaP given to patients with AML and MDS (RAEB2), CLL and BNHL is safe, feasible (i.e. compliance is reasonable) and has anti-cancer activity.<br> ;Secondary Objective: The study will also assess patient quality of life via validated quality of life questionnaire. The study will also register overall survival. ;<br> Primary end point(s): • Safety: The number of grade 3 and 4 Adverse Reactions and Serious Adverse Reactions (SARs) attributable to the trial drugs<br><br> • Patient compliance: Percentage of allocated treatment taken<br><br> • Activity:<br> o Haematological Response in the first 18 weeks of treatment<br> o Clinical Response in the first 18 weeks of treatment<br><br> ;Timepoint(s) of evaluation of this end point: When patients have been on treatment for 18 weeks.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Quality of Life<br> Overall survival will also be registered.<br> ;<br> Timepoint(s) of evaluation of this end point: Quality of life questionnaires completed at baseline will be compared to QoL questionnaires completed between week 7-11 and at week 18.<br>