ISRCTN15563554进行中（未招募）2 期
Repurposed drugs to improve haematological responses in myelodysplastic syndromes
niversity of Warwick0 个研究点目标入组 120 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 14/06/2023:
- •1. Provision of written informed consent
- •2. Age = 18 years and able to give informed consent
- •3. Diagnosis of myelodysplastic syndrome with an IPSS-R score of less than or equal to 3.5
- •4. Haematological parameters:
- •4.1. Mean haemoglobin < 100 g/l over 16 weeks (pre-transfusion) OR
- •4.2. Mean platelets < 100 x 109/L over 16 weeks + evidence of bleeding (assessed using the ISTH Bleeding Assessment Tool) OR
- •4.3. Mean neutrophils < 1.0 x 109/L over 16 weeks + history of infection (the requirement for antimicrobial therapy and hospital admissions associated with infection)
- •5. No response to erythroid stimulating agents (ESAs) OR have ceased to respond to ESAs OR are Predicated not to Respond to ESAs by current UK guidelines (NB Patients with thrombocytopenia and/or neutropenia, without anaemia, are eligible as they are predicated not to respond).
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •7. Expected survival > 12 months
- •Previous participant inclusion criteria:
- •1. Provision of written informed consent
- •2. Age =18 years and able to give informed consent
- •3. Diagnosis of myelodysplastic syndrome with an IPSS-R score of less than or equal to 3.51
- •4. Haematological parameters:
- •4.1. Mean haemoglobin <100 g/l over 16 weeks (pre-transfusion) OR
- •4.2. Mean platelets <100 x 10e9/l over 16 weeks + evidence of bleeding (assessed using the International Society on Thrombosis and Haemostasis (ISTH) Bleeding Assessment Tool) OR
- •4.3. Mean neutrophils <1.0 x 10e9/l over 16 weeks + history of infection (the requirement for antimicrobial therapy and hospital admissions associated with infection)
- •5. No response to erythroid stimulating agents (ESAs) OR have ceased to respond to ESAs OR are predicated not to respond to ESAs by current UK guidelines
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •7. Expected survival >12 months
排除标准
- •Current participant exclusion criteria as of 14/06/2023:
- •1. Abnormal liver function (if the patient has Gilbert’s syndrome, then abnormal direct bilirubin is an exclusion)
- •2. Cockcroft Gault CrCl < 20 ml/min
- •3. Current systemic treatment for low-risk MDS
- •4. History of allogeneic bone marrow transplant
- •5. History of having received ESAs and/or G-CSF in the past 16 weeks
- •6. Currently receiving statin medication for secondary prophylaxis of cardiovascular disease, cerebrovascular, or peripheral vascular disease (Please note patients receiving statin medication for primary prophylaxis of cardiovascular disease – i.e. the patient has no prior history of ischaemic heart disease or cerebrovascular disease - can still be entered
- •7. Currently receiving fibrate medications
- •8. Currently receiving sodium valproate, carbamazepine or phenytoin for the treatment of epilepsy
- •9. Prior cytotoxic chemotherapy or hypomethylating agents for AML/MDS (e.g. azacitidine)
- •10. Concurrent active malignancy requiring treatment
- •11. History of any androgen-dependent tumour (patients with prostate cancer are excluded when a biopsy-proven diagnosis of prostate cancer has been made OR their PSA is known to be elevated OR they are on active treatment for prostate cancer, including hormonal therapy).
- •12. Currently receiving vitamin K antagonist anticoagulation (though patients receiving direct oral anticoagulants (DOACs) can be included)
- •13. History of venous thromboembolism (VTE)
- •14. Cardiac failure NYHA Class III or IV
- •15. Women of childbearing potential, pregnant or lactating
- •16. The physician or patient considers VBaP or danazol to be inappropriate for the patient
- •17. Known HIV
- •18. Abnormally high CK level
- •19. Presence of isolated del 5q
- •20. Acute porphyria
- •21. Contraindications to any of the trial medications or known hypersensitivity to any of the investigational products
- •22. Previous randomisation in the REPAIR-MDS trial
- •23. Participation in a clinical trial of an investigational medicinal product in the last 16 weeks
- •Previous participant exclusion criteria:
- •1. Abnormal liver function (if the patient has Gilbert’s syndrome, then abnormal direct bilirubin is an exclusion)
- •2. Cockcroft Gault CrCl < 20 ml/min
- •3. Current systemic treatment for low-risk MDS
- •4. History of allogeneic bone marrow transplant
- •5. History of having received ESAs and/or G-CSF in the past 16 weeks
- •6. Currently receiving statin medication for secondary prophylaxis of cardiovascular disease or cerebrovascular disease (Please note patients receiving statin medication for primary prophylaxis of cardiovascular disease – i.e. the patient has no prior history of ischaemic heart disease nor cerebrovascular disease - can still be entered)
- •7. Currently receiving fibrate medications
- •8. Currently receiving sodium valproate, carbamazepine or phenytoin for treatment of epilepsy
- •9. Prior cytotoxic chemotherapy for AML/MDS
- •10. Concurrent active malignancy requiring treatment
- •11. History of any androgen-dependent tumour (patients with prostate cancer are excluded when a biopsy-proven diagnosis of prostate cancer has been made OR their PSA is known to be elevated OR they are on active treatment for prostate cancer, including hormonal therapy).
- •12. Currently receiving vitamin K antagonist anticoagulation (though patients receiving direct oral anticoagulants (DOACs) can be included)
- •13. History of venous thromboembolism (VTE)
- •14. Cardiac failure NYHA Class III or IV
- •15. Women of
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