EUCTR2012-002471-34-CZ进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-Dependent Anemia And Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes - QUAZAR lower-risk MDS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
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 years at the time of signing the informed consent document
- •2. Have a documented diagnosis of MDS according to WHO 2008classification
- •3. Be RBC transfusion-dependent as defined by:
- •Average transfusion requirement of = 2 units** per 28 days of RBCs
- •XML File Identifier: tJrERQxNxTNfard1XoJpn7JZNRQ=
- •confirmed for a minimum of 56 days immediately preceding
- •randomization (please note that the period covering the transfusion
- •history overlaps with the screening phase)
- •Hemoglobin levels at the time of or within 7 days prior to
- •administration of an RBC transfusion must have been = 10.0 g/dL in
- •order for the transfusion to be counted towards RBC transfusiondependent
- •status. Red blood cell transfusions administered when Hgb
- •levels were > 10.0 g/dL and/or RBC transfusions administered for
- •elective surgery will not qualify as a required transfusion for the purpose
- •of providing evidence of RBC transfusion-dependent status
- •- No consecutive 28 days that are RBC-transfusion-free during the 56
- •days immediately preceding randomization
- •4. Have thrombocytopenia as defined by two platelet counts that are =
- •75 x 109/L and = 21 days apart. The second confirmatory platelet count
- •must be obtained = 14 days prior to randomization
- •At least one platelet count must be centrally analyzed within the 56
- •day screening period with results of = 75 x 109/L; the second platelet
- •count may be centrally or locally analyzed, with results that are also =
- •75 x 109/L.
- •Prior documented medical history of thrombocytopenia may be used
- •to demonstrate
- •eligibility for the study if at least one historical platelet count of = 75 x
- •109/L was obtained within 56 days of randomization and = 21 days
- •apart from the centrally
- •analyzed platelet count.
- •If additional platelet counts were obtained during the interim period,
- •these must also have been = 75 x 109/L. If platelet counts within the
- •interim period are >75 x 109/L, this would be acceptable only if directly
- •associated with a platelet transfusion administered within 7 days prior
- •to the date of the platelet count.
- •5. Have an ECOG performance status of 0, 1, or 2
- •6. Females of childbearing potential (FCBP)†† may participate, providing
- •they meet the following conditions:
- •Agree to use at least two effective contraceptive methods (oral,
- •injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine
- •device; barrier contraceptive with spermicide; or vasectomized
- •partner) throughout the study, and for 3 months following the last dose
- •Have a negative serum pregnancy test at screening ; and
- •Have a negative serum or urine pregnancy test (investigator's
- •discretion; sensitivity of at least 25 mIU/mL) within 72 hours prior to
- •starting IP in the treatment phase (note that the screening serum
- •pregnancy test can be used as the test prior to starting study therapy in
- •the treatment phase if it is performed within the 72-hour timeframe)
- •7. Male subjects with a female partner of childbearing potential must
- •agree to the use of at least two physician-approved contraceptive
- 另有 3 项未显示
排除标准
- •1. IPSS higher-risk (INT-2 or High risk) MDS
- •2. Secondary MDS, 3. Hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy based on investigator's judgement, unless subject received last dose from prior Chemo~ or Immunotherapy = 24 weeks prior to randomization
- •4. CMML, atypical chronic myeloid leukemia (CML) and unclassifiable myeloproliferative disease (MPD)
- •5. Prior treatment with any of the following:
- •- Azacitidine (any formulation), decitabine or other hypomethylating agent
- •- Lenalidomide, unless the subject received the last dose = 8 weeks prior to randomization
- •6. Prior allogeneic or autologous stem cell transplant
- •7. History of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the IP and/or predispose the subject to an increased risk of gastrointestinal toxicity
- •8. Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s) (eg, idiopathic thrombocytopenic purpura [ITP]), or microvascular disorder(s) (eg, disseminated intravascular coagulation, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura)
- •9. Use of any of the following within 28 days prior to randomization:
- •- cytotoxic, chemotherapeutic, targeted or investigational agents/therapies
- •- thrombopoiesis-stimulating agents (TSAs; eg, Romiplostim, Eltrombopag, Interleukin-11)
- •- ESAs and other RBC hematopoietic growth factors (eg, Interleukin-3)
- •- hydroxyurea
- •10. Ongoing medically significant adverse events from previous treatment, regardless of the time period
- •11. Concurrent use of any of the following:
- •- iron-chelating agents, except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization
- •- corticosteroid, except for subjects on a stable or decreasing dose for = 1 week prior to randomization for medical conditions other than MDS
- •12. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for = 3 years. However, subjects with the following history/concurrent conditions are allowed:
- •- Basal or squamous cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of the breast
- •- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system)
- •13. Significant active cardiac disease within the previous 6 months, including:
- •- New York Heart Association (NYHA) class IV congestive heart failure;
- •- Unstable angina or angina requiring surgical or medical intervention; and/or
- •- Myocardial infarction
- •14. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate
- •antibiotics, antiviral therapy, and/or other treatment)
- •15. Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
- •16. Abnormal coagulation parameters (PT > 15 seconds, PTT > 40
- •seconds, and/or INR > 1.5). After consultation with the medical monitor,
- •higher than normal range levels may be acceptable if the subject is being
- •treated with a stable dose of anticoagulants for thrombotic prophylaxis
- •(ie with at
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