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., A Pfizer Company0 个研究点目标入组 60 人开始时间: 2009年4月8日最近更新: 2013年4月1日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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 (including DLBCL with follicular elementsand transformed indolent lymphoma with DLBCL) with 1 or 2 prior therapies with curative intent; 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. Persistent disease (partial response or stable disease) or relapsed disease occurring < 12 months after start of the most recent prior therapy.
•b. Secondary International Prognostic Index (sIPI) score > 1 (irrespective of duration of prior response).
•2. Eligible for aSCT.
•3. Male and female subjects aged 18 years or older.
•4. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1500/µL) and platelets = 100 x 10^9/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 product diameters = 2.25 cm^2 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 regardless if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
•12. Signed and dated institutional review board (IRB/independent ethics committee (IEC)-approved informed consent form before any screening procedures are performed.
•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 their most recent chemotherapy regimen (with or without rituximab), defined as disease progression during the regimen, within = 3 weeks after completion of regimen, or
•if the first response assessment associated with the regimen shows disease progression.
•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 (eg, Wegener's granulomatosis, polyartertitis nodosa, systemic lupus erythematosus).
•8. Immunocompromised subjects, including current or chronic hepatitis B or C infection (as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively), 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 dose at least 7 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.
•22. The person concerned has been committed to an institution by virtue of an order issued either by the judicial
•or the administrative authorities.
•23. History of clinically significant ventricular arrhythmia, prolonged QTc interval, or
•unexplained syncope.
•24. Screening QTcF interval > 470 msec.

研究者

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc., A Pfizer Company

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已完成

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PER-040-08ABORATORIOS WYETH S.A.,

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