EUCTR2009-017098-40-GB进行中（未招募）1 期
se of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure (DEC-MDS) - DEC-MDS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
入选标准
- •1.Written signed informed consent.
- •2.18 years of age or older
- •3.At study entry, diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts (previously defined as RAEB-t by the FAB MDS classification).
- •4.Patients who have failed therapy with azacitidine* see definition below.
- •5.Performance status 0-2 (ECOG scale).
- •6.Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions (creatinine <1.5 X ULN).
- •*Failure of treatment with 5-azacitidine is defined as:
- •1.Refractory
- •Progression, immediately and without reaching prior response (CR, PR, mCR, HI), under therapy with 5-azacitidine given for at least 6 cycles
- •2.Relapsed on therapy
- •Progression, after prior response (CR, PR, mCR, HI, SD), under therapy with 5-azacitidine
- •3.Relapsed off therapy
- •Patients who had previously attained a response (CR, PR, mCR, HI, SD) while on 5-azacitidine, but have subsequently relapsed within 3 months from last 5-azacitidine course
- •4.Toxicity failure
- •5-azacitidine-related non-haematological toxicity precluding its further administration
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Patients with >30% bone marrow blasts at study entry.
- •2.Nursing and pregnant females.
- •3.Women of childbearing potential (WCBP) † and males not willing to practice an effective method of contraception whilst receiving decitibine and for 2 months after the last infusion.
- •† A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oopherectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
- •4.Patients with concurrent malignancy.
- •5.Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
- •6.Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
- •7.Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
- •8.Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose) for the treatment of MDS or AML. (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
- •9.Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
- •10.Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
- •11.Patients who have previously been treated with decitabine.
- •12.Patients who have known positive serology for HIV.
- •13.Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
研究者
相似试验
Unknown
2 期
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) FailureAcute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic LeukemiaNCT01133886King's College London50
终止
2 期
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine FailureMyelodysplastic SyndromeChronic Myelomonocytic LeukemiaNCT00113321M.D. Anderson Cancer Center16
Unknown
1 期
Dose Finding Study of Post-BMT Decitabine Maintenance Treatment in Higher-risk MDS and MDS/AMLAcute Myeloid LeukemiaMyelodysplastic SyndromeNCT01277484Seoul St. Mary's Hospital19
Unknown
3 期
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaNCT00043134European Organisation for Research and Treatment of Cancer - EORTC220
No Longer Available
不适用
An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)Myelodysplastic SyndromesNCT01026376Janssen-Cilag Farmaceutica Ltda.