EUCTR2014-000200-10-IT进行中（未招募）1 期
A Randomized Phase III study of Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)
Fondazione Italiana Sindromi Mielodisplastiche (FISM Onlus)0 个研究点目标入组 168 人开始时间: 2014年9月17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
- 168
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
- •1- age 18 and older
- •2- CMML as defined by:
- •- Diagnosis according to WHO criteria
- •-Stable excess in blood monocytes, > 1 Giga/L
- •-Lack of bcr-abl rearrangement (or Philadelphia chromosome)
- •-Bone marrow blast cells < 20%
- •-Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation.
- •- WBC = 13 G/L
- •- At least two of the following criteria: (adapted from Wattel et al. Blood 1996)
- •-Marrow blasts =5 %
- •-Clonal cytogenetic abnormality other than t(5;12) (q33; p13) and loss of Y chromosome
- •-ANC > 16 G/l in the absence of an active infection
- •-Anemia (Hb < 10 g/dL)
- •-Thrombocytopenia (platelet count < 100 G/L)
- •-Splenomegaly > 5 cm below costal margin (spleen size should also be measured by an imaging technique)
- •Or: Extramedullary localization (including documented cutaneous, pleural or pericardial effusion)
- •3- No prior treatment (except supportive care, or ESA, or short term (< 6 weeks) HY in patients presenting with high WBC counts)
- •4- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •5- Adequate organ function including the following
- •-Liver : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or due to Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
- •-Renal : serum creatinine < 2 times ULN
- •6- Signed informed consent
- •7- Negative pregnancy and adequate contraception (including in male patients) if relevant.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •-Myeloproliferative / myelodysplastic syndrome other than CMML
- •-Patients eligible for allogeneic bone marrow transplantation with an identified donor
- •-CMML with t(5 ;12) or PDGF?R rearrangement that may be treated with imatinib
- •-Pregnant or breastfeeding
- •-Performance status > 2 on the ECOG Scale.
- •-Serious concomitant systemic disorder, including active bacterial, fungal or viral infection that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the stud
- •-Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
研究者
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