Elderly and relapsed high risk acute myeloid leukaemia Cancer Myeloid leukaemia
Conditions
Interventions
1. Bezafibrate (Bezalip-Mono) 400 mg daily
2. Medroxyprogesterone acetate (Provera) 200 mg twice daily
Patients will also be given a prophylactic vitamin supplement so that they are not deficient in
one patient is still alive.
Sponsors
University Hospital Birmingham NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has acute myeloid leukaemia (this can be any type of de novo or secondary AML, except acute promyelocytic leukaemia), or 2. Patient has refractory anaemia with an excess of blasts (greater than 10%) RAEB type 2 World Health Organization (WHO) criteria 3. Adult patients, either sex
Exclusion criteria
Exclusion criteria: 1. Patient has acute promyelocytic leukaemia 2. Intensive chemotherapy is considered a suitable option 3. Low dose cytotoxic chemotherapy is likely to be required to control a rising blast cell count in the next month 4. Patient has a concurrent active malignancy 5. Patient has uncontrolled systemic disease (e.g. hypertension, diabetes) or severe cardiovascular disease 6. Patient is pregnant or lactating, or are potentially fertile (both males and females) and have not agreed to take adequate contraceptive precautions during the trial 7. Patient aged under 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumour response as measured by: 1. Full blood count 2. Transfusion dependency (frequency of red blood cells/platelet transfusions) 3. Percentage blasts in bone marrow and peripheral blood pre and post BaP therapy 4. Bone marrow morphology as determined by blood smears Response will be assessed using Southwest Oncology Group (SWOG) criteria as modified from National Cancer Institute (NCI-) sponsored workshop guidelines. 1. Complete response (CR): less than 5% blasts in a marrow of sufficient cellularity with a peripheral neutrophil count greater than 1 x 10^9/l and platelet count of greater than 100 x 10^9/l determined by two evaluations not less than 4 weeks apart 2. Partial response (PR): as determined by two evaluations not less than 4 weeks apart: 2.1. In RAEB type 2 bone marrow should show greater than 50% decrease in myeloblasts, but not necessarily disappearance of marrow dyspoiesis. In peripheral blood, greater than 50% reduction in deficit from minimum normal levels (UHB haematology reference range) of the haemoglobin, neutrophil and platelet counts (if abnormal at baseline) with an absence of myeloblasts in the peripheral blood. 2.2. In AML bone marrow should show less than 15% myeloblasts with a decrease but not necessarily a disappearance of marrow dyspoiesis with an absence of Auer rods. Plus in peripheral blood there should be a greater than 50% reduction in deficit from minimum normal levels (UHB haematology reference range) of haemoglobin, neutrophil and platelet counts (if abnormal at baseline) with absence of myeloblasts in the peripheral blood. 3. Minor response (MR): decrease in frequency of infections or bleeding episodes and a 50% decrease in transfusion requirements, decrease of marrow dyspoiesis and improvement in peripheral counts but not enough to qualify for PR or CR nor progressive disease can be established 4. No change: neither the criteria for CR, PR, MR nor progressive disease can be established 5. Progressive disease: evidence of inc | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed