EUCTR2007-002212-26-FR进行中（未招募）不适用
A Phase I/II Study of Vorinostat in Combination with Low Dose Ara-C for Patients with Intermediate-2 or High Risk Myelodysplastic Syndromes - GFM-VOR-2007-1
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Patient has MDS including the following FAB sub-types: refractory anemia with blast excess (RAEB) ,transformed refractory anemia with blast excess (RAEB-t) and non proliferative Chronic MyeloMonocytic Leukemias (WBC below 13G/l).
- •2.Patient has a IPSS score > 1. 5 (INT-2 and high risk categories).
- •3.Patient is male or female, and = 18 years of age on day of signing informed consent.
- •4.Patient has an Eastern Cooperative Oncology Group (ECOG) performance s
- •tatus =2 (See Appendix 6.1).
- •5.Patient has recovered from toxicities due to prior therapy (less than grade 2) except for cytopenia
- •6.Patient must have adequate organ function as indicated by the following laboratory values:
- •?Serum creatinine or calculated creatinine clearancea < 2 mg/dl or = 60 mL/min for patients with creatinine levels > 1.5 X institutional ULN Hepatic
- •?Serum total bilirubin = 2.5 X ULN or direct bilirubin = ULN for patients with total bilirubin levels = 2 mg/dL.
- •?AST (SGOT) and ALT (SGPT)= 2.5 times ULN
- •?Alkaline Phosphatase = 5 X ULN If > 2.5 X ULN, then liver fraction
- •should be = 2.5 X ULN
- •(Creatinine clearance should be calculated per institutional standard)
- •7.Patient is known to not be refractory to platelet transfusions.
- •8.Female patient of childbearing potential has a negative serum pregnancy test (ß-hCG) within 72 hours prior to receiving the first dose of vorinostat and or Ara-C . Female patient is not actively breastfeeding at the time of study entry.
- •9.Female patient is either post-menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from becoming pregnant throughout the study, starting with Visit 1.
- •10.Male patient agrees to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving vorinostat and for 1 month post study.
- •11.Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
- •12.Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
- •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
- •1.Patient had prior treatment with an HDAC inhibitor (e.g., depsipeptide or NSC-630176, MS 275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period.
- •2.Patient has been previously treated with low dose (20 mg/m2 SC daily) Ara-C for MDS within 3 months of beginning this study.
- •3.Patient with RAEB-2 or RAEB-T eligible for intensive chemotherapy followed or not by allogeneic stem cell transplantation
- •4.Patient has active and uncontrolled infection
- •5.Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
- •6.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
- •7.Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
- •8.Patient has clinically active hepatitis B or hepatitis C infection.
- •9.Patient has a known allergy or hypersensitivity to any component of vorinostat or Ara-C.
- •10.Patient with a currently active second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a currently active malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse.
- •11.Patient has received growth factors such as epoetin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF) or has received non cytotoxic agents (including low dose oral chemotherapy) in the 30 days before inclusion. In case of previous cytotoxic treatment, an interval of 3 months is required.
- •12.Patient is on any systemic steroids that have not been stabilized to the equivalent of = 10 mg/day prednisone during the 4 weeks prior to the start of the study drugs
- •13.Patients with clinical evidence of CNS leukemia.
- •14.Patient has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drugs.
- •15.Patient is unable to take and/or tolerate oral medications on a continuous basis.
研究者
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