EUCTR2008-007802-12-FR进行中（未招募）1 期
An Open-label, Single-Arm, Phase 2 Study of Inotuzumab Ozogamicin Plus Rituximab in Subjects With Relapsed/Refractory CD22-Positive Diffuse Large B-Cell Lymphoma, Eligible for Autologous Stem Cell Transplantation
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 60 人开始时间: 2009年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects with a diagnosis of CD20 and CD22-positive DLBCL who have relapsed after achieving a complete or partial response or whose best response was stable disease after 1 or 2 prior regimens; one prior chemotherapy regimen must have contained anthracyclines (with or without rituximab) and one regimen must have included rituximab in combination with chemotherapy. Disease status at the time of first dosing requires at least one of the following characteristics:
- •a. Relapsed or disease progression occurring < 12 months after start of the prior therapy.
- •b. Secondary International Prognostic Index (sIPI) score > 1.
- •2. Eligible for aSCT.
- •3. Male and female subjects aged 18 years or older.
- •4. Absolute neutrophil count (ANC) = 1.5 x 109/L (1500/µL) and platelets = 100 x 109/L (100,000/µL).
- •5. Total bilirubin = 1.5 x upper limit of normal (ULN), aspartate and alanine aminotransferase (AST, ALT) = 2.5 x ULN.
- •6. At least 1 measurable disease lesion that is = 1.0 cm in 2 perpendicular dimensions, with the sum of the product diameters > 2.25 cm2 by computed tomography (CT) or magnetic resonance imaging (MRI).
- •7. Serum creatinine = 2.0 x ULN and urine protein/creatinine ratio =0.5.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •9. Life expectancy =3 months.
- •10. Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- •11. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study, including up to 18 months after the last dose of induction therapy test article. A subject is biologically capable of having children if he or she is using
- •contraceptives or if his or her sexual partner is sterile or using contraceptives.
- •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. Prior allogeneic hematopoietic stem cell transplant (HSCT).
- •2. Prior autologous transplant =6 months before first dose of test article.
- •3. Prior treatment with anti-CD22 antibodies; or previous radio-immunotherapy =6 months before first dose of test article.
- •4. Subjects whose disease progressed while receiving rituximab in combination with chemotherapy.
- •5. History of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
- •6. Intolerance to rituximab or history of severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies.
- •7. Known systemic vasculitides.
- •8. Immunocompromised subjects, including current or chronic hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV).
- •9. Evidence of serious active infection (eg, requiring an intravenous [IV] antibiotic or antiviral agent).
- •10. Major surgery, not related to debulking surgical procedures, =28 days before first dose of test article.
- •11. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices =28 days before first dose of test article. Subjects receiving high doses of corticosteroids must have been tapered to a stable and acceptable dose at least 28 days before the first dose of inotuzumab ozogamicin
- •12. Pregnant or breastfeeding women.
- •13. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
- •14. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
- •15. Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for =2 years.
- •16. Primary effusion lymphoma.
- •17. Cardiac function, as measured by left ventricular ejection fraction (LVEF) that is less than 50%, or the presence of New York Heart Association (NYHA) stage III or IV congestive heart failure.
- •18. Previous myocardial infarction or pulmonary hypertension =6 months before first dose of test article.
- •19. History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- •20. Administration of a live vaccine =6 weeks before first dose of test article.
- •21. Any major illness/condition or abnormal laboratory finding that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study.
研究者
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