CTRI/2009/091/001086已完成3 期
An open label, multi-centric, single arm, non-randomized,prospective study to assess the efficacy and safety ofRecombinant Human Interleukin-11 (Oprelvekin) inprevention and treatment of chemotherapy inducedThrombocytopenia in adult cancer patients
upin Limited0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
入选标准
- •.Subjects of either sex, aged > 18 years
- •.Documented and confirmed non-myelogenous solid tumor or lymphoma on chemotherapy
- •.Have experienced thrombocytopenia (platelet count of <50,000 cells/ µL) in the cycle immediately prior to their entry into the study.
- •.Recovered to a platelet count > 1,00,000 cells/µL before initiating the Study Cycle (X+1)
- •.Bilirubin, SGOT & SGPT of < 2.5 ULN before initiating Study Cycle (X+1)
- •.Serum Creatinine of < 2 mg/dl before initiating Study Cycle (X+1)
- •.BUN of < 2 x ULN before initiating Study Cycle (X+1)
- •.Planned to be undergoing at least two more Cycles of chemotherapy with the same chemotherapy regimen without change in dose.
- •.ECOG performance status of < 2 at screening.
- •.Non-pregnant and non-nursing women. If are of child bearing potential must use effective contraceptive measures during the entire study duration.
- •.Subjects providing written informed consent and willing to undergo all study related procedures.
排除标准
- •.Known allergies to E.Coli proteins
- •.Patient has known hypersensitivity to IL-11 or any component of Oprelvekin.
- •.Prior treatment with Oprelvekin / IL-11 in previous cycle
- •.History of rapidly progressive disease
- •.Received Aspirin, NSAID?s, anti-coagulant drugs (except low dose anti-coagulation to prevent catheter thrombosis) within 7 days prior to initiating Chemotherapy Cycle X+1
- •.Prior cumulative dose of Doxorubicin >300 mg/m2.
- •.History of Autoimmune Diseases, Thromboembolic disease, except catheter related thrombosis or coagulation factor deficiencies
- •.Severe Hypokalemia
- •.Existing active infection requiring systemic antibiotics at the time of enrolment
- •.Known HIV or HBsAg positive patients
- •.Patients with Leukemia, Stem Cell Transplant or Bone Marrow Transplant recipients within 60 days prior to screening
- •.Patients with history of Atrial Arrhythmias or congestive heart failure or patients with New York Heart Association (NYHA) Class III or IV or LVEF <45%
- •.History of CNS Involvement or Metastasis
- •.Any significant medical or surgical condition which in the opinion of investigator would interfere with the study participation.
- •.Pregnant and lactating women
- •.Any prior or current involvement of bone marrow by tumor
- •.Subjects who were previously included or had participated in any other clinical study within 90 days prior to the date of consent.
- •.Prior surgery or radiotherapy within 4 weeks prior to study entry or anticipated to require radiotherapy during the course of study
- •.History of prior Pelvic Irradiation
- •.No other active primary malignancy in last 5 years, other than the one for which chemotherapy is being instituted in the current study.
研究者
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