A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

Seattle Genetics, Inc.0 个研究点目标入组 224 人开始时间: 2007年9月21日最近更新: 2021年10月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 224

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. Patient has pathologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), including both de novo and transformed DLBCL and follicular lymphoma, Grade 3b (FL3b). Local pathology review is acceptable for determining eligibility. Patients who have relapsed more than 12 months since completing R-CHOP must have a biopsy to confirm histology.
•2. Patient has received at least four cycles of first-line therapy with R-CHOP or equivalent first-line therapy including rituximab, cyclophosphamide, anthracyline or anthracenedione, and steroid with or without additional chemotherapy agent(s). For patients who achieve CR with first-line therapy, maintenance rituximab prior to relapse is allowed.
•3. Patient had a best clinical response to first-line therapy of stable disease, partial response, or complete response.
•4. Patient currently has at least one site of measurable disease meeting both of the following criteria:
•- Bidimensional measurement with longest axis greater than or equal to 2 cm by radiographic imaging.
•- Positive FDG-PET scan at baseline.
•5. A fresh or archived tumor specimen is available for central review to confirm diagnosis, assess expression levels of CD40 and other B cell surface markers (e.g., CD79a, CD19, CD20) on malignant tumor cells, perform immunohistochemical studies to determine DLBCL subtype and/or for gene expression profiling by cDNA microarray analysis.
•6. Patient has completed first-line therapy at least four weeks prior to the date of randomization.
•7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
•8. Patient is at least 18 years old and no more than 75 years old.
•9. Patient has the following required baseline laboratory data (eligibility can be based on local lab results):
•- Platelet count greater than or equal to 75,000/mm3.
•- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 (may be maintained by growth factors).
•- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal (ULN).
•- Total serum bilirubin level less than or equal to 1.5 times ULN.
•- Serum creatinine less than or equal to 1.5 times ULN.
•10. If a female of childbearing potential, the patient has a negative urine pregnancy test result (sensitivity at least 50 mIU/mL) within three days prior to the first dose of Investigational Drug or on Day -2, prior to first dose. (Females of non-childbearing potential are those who are postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy)
•11. If female of childbearing potential or a male patient, patient agrees to use an effective contraceptive method from the time of informed consent, during the course of the study, and for six months following the last dose of Investigational Drug.
•12. Patient is available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
•13. Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
•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. Patient has a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
•2. Patient has received any therapy for relapsed or progressive disease except for local radiation, steroids, or single-agent rituximab (less than or equal to four infusions).
•3. Patient has a documented history of a cerebral vascular event (stroke or transient ischemic attack) or myocardial infarction within six months of screening.
•4. Patient has received a hematopoietic stem cell transplant.
•5. Patient has been previously treated with an anti-CD40 mAb or any therapeutic radiolabeled antibody.
•6. Patient has had major surgery within four weeks prior to randomization.
•7. Patient has a known hypersensitivity or anaphylactic reaction to any component of the planned study treatment.
•8. Patient has evidence of another invasive primary malignancy anytime in the 12 months prior to screening.
•9. Patient has had any systemic viral, bacterial, or fungal infection requiring IV antibiotics within four weeks prior to planned date of randomization.
•10. Patient has a known positive test for human immunodeficiency virus (HIV), hepatitis B (by surface antigen expression), or hepatitis C infection.
•11. Patient is on systemic steroids exceeding 20 mg/day prednisone or equivalent during any of the seven days prior to randomization.
•12. Patient is taking any other systemic immunosuppressive medication during the 14 days immediately prior to randomization (e.g., cyclosporine, azathioprine, mycophenylate mofetil).
•13. Patient is pregnant or breastfeeding.
•14. Patient has any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment or subsequent SCT.
•15. Patient has been diagnosed with dementia or has altered mental status that would preclude the understanding and/or rendering of informed consent.

研究者

发起方

Seattle Genetics, Inc.

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