EUCTR2014-000200-10-DE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)
Groupe Francophone des Myélodysplasies (GFM)0 个研究点目标入组 168 人开始时间: 2014年5月26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
- •A/ Age = 18
- •B/ CMML diagnosis according to WHO criteria
- •-Stable excess in blood monocytes, > 1 G/L and accounting for > 10% WBC
- •-Lack of bcr-abl rearrangement (or Philadelphia chromosome). There should be at least one BCR-ABL test (cytogenetics or molecular biology) dating from the date of CMML diagnosis up to date of screening.
- •-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
- •-Blood and marrow smears will be reviewed at each country’s level, but morphologist meetings at the 3 country level are planned for better harmonization and review of difficult cases
- •C/ WBC = 13 G/L
- •Measured on two successive CBC at least two weeks apart, outside of a context of infection and before initiation of treatment by Hydroxyurea.
- •D/ Either D1 or D2
- •D1/ At least two of the following criteria, reviewed at each country’s level: (modified from Wattel et al. Blood 1996)
- •-Marrow blasts >= 5 %
- •-Clonal cytogenetic abnormality (other than t(5;12) (q33; p13) and isolated loss of Y chromosome )
- •-Anemia (Hb < 10 g/dL)
- •-ANC > 16 G/l (in absence of infection)
- •-Thrombocytopenia (platelet count < 100 G/L)
- •-Splenomegaly > 5 cm below costal margin (spleen size should also be measured by an imaging technique)
- •D2/ Extramedullary involvement: Including documented cutaneous, pleural or pericardial effusion.
- •E/ No prior treatment (except supportive care, or ESA, or short term (< 6 weeks before the screening date) HY in patients presenting with high WBC counts). The 6-week period for HY treatment can be prolonged to no more than 8 weeks in patients to allow complete exclusion of donor availability in patients fit for allogeneic stem cell transplantation lacking sibling donors.
- •F/ Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •G/ Adequate organ function including the following
- •-Hepatic : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) < 3xULN
- •-Renal : serum creatinine < 2 x ULN
- •H/ Signed Informed consent
- •I/ Negative pregnancy and adequate contraception (including in male patients wishing to father) if relevant.
- •Female subjects of chilbearing potential* must:
- •* A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
- •- Age = 50 years and naturally amenorrhoeic for = 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential)
- •- Premature ovarian failure confirmed by a specialist gynaecologist
- •- Previous bilateral salpingo-oophorectomy, or hysterectomy
- •- XY genotype, Turner syndrome, uterine agenesis.
- •Agree to have a medically supervised pregnancy test on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment.
- •Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These pregnancy tes
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)
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