EUCTR2007-002532-28-GB进行中（未招募）1 期
A Phase II Study of Efficacy of Rabbit Anti-thymocyte Globulin (rATG) in patients with Low and Itermediate-1 Risk Mylodysplastic Syndrome - Genzyme ThymoHEMO1206: Phase II study of Thymoglobulin in MDS patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
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.Provides signed written informed consent.
- •2.Has pathologically confirmed MDS with a low or intermediate-1 risk score as assessed by IPSS at the time of MDS diagnosis and at time of screening.
- •3.Has received no more than 1 prior treatment for MDS (excluding supportive care such as transfusions and antibiotics), which is restricted to the following treatments that may have been administered as a standard treatment or as an investigational agent. Treatment with any of these agents must have been discontinued at least 4 weeks before Day 1 of the study treatment.
- •Hematopoietic growth factors: EPO or any EPO derivative with or without concurrent granulocyte colony stimulating factor (G CSF) and/or granulocyte-macrophage colony stimulating factor GM-CSF)
- •(For patients where EPO is an available therapy (country specific), the Investigator must determine that the patient either demonstrated a lack of response to EPO or did not meet the criteria predictive for an intermediate or high response as defined by the predictive model.)
- •Prior treatment is restricted to azacitidine, decitabine, lenalidomide, or thalidomide.
- •4.Exhibited at least 1 of the following hematologic cytopenias as determined from at least 2 time points over at least a 1-week period.
- •Anemia (hemoglobin <11 g/dL)
- •Neutropenia (ANC <0.5 x 10*9 /L)
- •Thrombocytopenia (platelets <20 x10*9 /L).
- •5.Have documentation of prior transfusion requirements for the preceding 8 weeks and total duration of any ongoing RBC transfusion dependence.
- •6.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- •7.Be =18 and =60 years of age at the time of signing the informed consent document (ICD).
- •8.Is able to adhere to study visit schedule and all other protocol requirements.
- •9.Is willing to practice a medically approved method of birth control during participation in the study (at least 12 months after the last infusion of rATG) (fertile male and female patients).
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Is pregnant or lactating.
- •2.Has had prior treatment with any ATG, cyclosporin, or any other immunomodulatory or immunosuppressing agent.
- •3.Has had a prior HSCT and/or other organ transplant.
- •4.Has had a prior allergic reaction to rabbit proteins or excipients.
- •5.Has 1 of the following subtypes of MDS:
- •refractory anemia with ringed sideroblasts (RARS), according to WHO classification, or
- •chronic myelomonocytic leukemia CMML if WBC count >13 x 10*9 /L, or
- •other MDS types of the MDS/myeloproliferative diseases (MPD) group according to WHO classification.
- •6.Has MDS associated with a 5q chromosomal deletion based upon local bone marrow cytogenetic analysis, unless the patient received prior lenalidomide treatment.
- •7.Has MDS presumed secondary to exposure to chemicals or treatment with radiotherapy or chemotherapy.
- •8.Received any treatment with an investigational agent, except the accepted previous treatments, within 4 weeks prior to the first infusion of rATG.
- •9.Has a serum creatinine >1.5 x upper limit of normal (ULN).
- •10.Received any treatment with non-steroidal anti-inflammatory drugs (NSAID) within 14 days prior to start of study treatment.
- •11.Has aspartate transaminase (AST) and alanine transaminase (ALT) >2.5 x ULN.
- •12.Has serum total bilirubin >1.5 ULN except for unconjugated hyperbilirubinemia related to the patient’s MDS.
- •13.Is known to be human immunodeficiency virus (HIV) positive.
- •14.Has any prior diagnosis of malignancy other than MDS, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions:
- •Patients with treated basal-cell skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed,
- •Patients with organ-confined prostate cancer, with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values, are also eligible for this study, if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- •15.Any serious medical condition (other than MDS) that would limit survival to ?2 years.
- •16.Active acute or chronic infection, including active cytomegaloviremia (CMV) infection with positive immunoglobulin M (IgM) titers, and/or CMV-DNA-PCR positive copy numbers, or deep tissue infection.
- •17.Any other serious medical condition, uncontrolled illness (including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia), social condition, or psychiatric illness that will prevent the patient from signing the ICD, or will place the patient at unacceptable risk if he/she participates in the study, or that would limit compliance with study requirements.
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