EUCTR2005-003985-40-BE进行中（未招募）1 期
A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM) - zoledronic acid in myelofibrosis
Department of Internal Medicine, University Hospital Gasthuisberg0 个研究点目标入组 16 人开始时间: 2005年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?male or female and at least 18 years-of-age
- •?histologically confirmed diagnosis of myelofibrosis with myeloid metaplasia (MMM). This includes patients with agnogenic myeloid metaplasia (also known as idiopathic myelofibrosis) and patients with a preceding history of polycythemia vera or essential thrombocytemia (also known as post-polycytemic myelofibrosis). (see Appendix A)
- •?patients with low, intermediate and high risk disease categories may be included. (see Appendix C)
- •- low risk meaning: Hb > 10 g/dl, and WBC between 4 and 30 x 109/l
- •- intermediate risk meaning:Hb < 10 g/dl, or WBC < 4, or > 30 x 109/l
- •- high risk meaning:Hb < 10 g/dl, and WBC < 4 or > 30 x 109/l
- •?presence of measurable, clinically relevant disease manifestations (especially for low risk patients)
- •?ECOG performance status of 0, 1 or 2
- •?life expectancy of at least 3 months
- •?Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization.
- •?written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 disease or acute panmyelosis with myelofibrosis)
- •?presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement as detected by RT-PCR in bone marrow or peripheral blood
- •?any anti-myelofibrosis drug therapy during the last 4 weeks. This includes chemotherapy, androgens, steroids, thalidomide, hematopoietic growth factors or any other investigational drug
- •?patients that have received bisphosphonates in the previous 3 months
- •?known allergy or intolerance to bisphosphonates
- •?abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/min (creatinine clearance (CrCl) is calculated using the Cockcroft and Gault formula) (see Appendix F)
- •?corrected serum calcium < 8.0 mg/dL . Corrected serum calcium (mg/dl) = measured calcium (mg/dl) + 0.8*[4 – patient serum albumin (g/dl)]
- •?patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
- •?uncontrolled infections
- •?uncontrolled type 2 Diabetes Mellitus
- •?diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
- •?cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
- •?current active dental problems including infection of the teeth or jawbone (maxilla or mandibula); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
- •?recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- •?patients with a history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
- •?patients treated with any systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
- •?pregnant or breast feeding females
研究者
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