NL-OMON47302已完成3 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. - Celgene AZA-MDS-003
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 2008
- •classification
- •3. Be RBC transfusion-dependent as defined by:
- •Average transfusion requirement of >= 2 units** per 28 days of RBCsconfirmed 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
- •methods throughout the course of the study and should avoid fathering a
- 另有 1 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 judgment, 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
- •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,
- •New York Heart Association (NYHA) class IV congestive heart failure;
- •Unstable angina or angina requiring surgical or medical intervention;
- 另有 8 项未显示
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