A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM)

niversity Hospital Leuven - Department of Haematology0 个研究点目标入组 16 人开始时间: 2007年8月27日最近更新: 2021年10月8日

试验速览

暂无简介。

•- written informed consent
•- at least 18 years-of-age
•- histologically confirmed diagnosis of MMM (include idiopathic myelofibrosis, polycythemia vera and essential thrombocytemia)
•- presence of measurable, clinically relevant disease manifestations
•- 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
•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

•- diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodisplasia, hairy cell leukemia, mast cell disease, acute leukemia
•- presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement
•- 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 biphosphonates in the previous 3 months
•- known allergy or intolerance to bisphosphonates
•- abnomal renal function (calculated creatinine clearance < 30mL/min )
•- corrected serum calcium < 8.0 mg/dL.
•- current active dental problems, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed in the mouth, or of slow healing after dental procedures
•- patients with nonmalignant conditions wich 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, disease with influence on bone metabolism such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction, cardiovascular, renal, hepatic, pulmonary, and neurologic/psychiatric disease wich would prevend prolonged follow-up)
•- pregnant or breast feeding females

发起方

niversity Hospital Leuven - Department of Haematology