EUCTR2020-001021-31-DE进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF GLOFITAMAB INCOMBINATION WITH GEMCITABINE PLUS OXALIPLATIN VERSUS RITUXIMAB IN COMBINATION WITH GEMCITABINE AND OXALIPLATIN IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE BCELL LYMPHOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 274
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
- •Age >= 18 years
- •Life expectancy >= 12 weeks
- •Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS)
- •Relapsed or refractory disease
- •At least one line of prior systemic therapy
- •Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant
- •Confirmed availability of tumor tissue, unless unobtainable per investigator assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable
- •At least one bi-dimensionally measurable nodal lesion, or one bi-dimensionally measurable extranodal lesion, as measured on CT scan
- •Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- •Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen or polymerase chain reaction (PCR) test within 7 days prior to enrollment
- •SARS-CoV-2 PCR testing and negative result within 48 hours before study treatment administration at each treatment cycle (only applicable to French study sites)
- •Vaccination status in line with French National guidelines/recommendations (only applicable to French study sites)
- •Adequate hematologic function; adequate renal function
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive measures with a failure rate of <1% per year, and
- •agreement to refrain from donating eggs, during the treatment period
- •and for at least 18 months after the final dose of obinutuzumab, 12
- •months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, 4 months after the final dose of tocilizumab, and 4 months after the final dose of
- •glofitamab.
- •For men: with a female partner of childbearing potential or a pregnant female partner, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year, and men must agree to refrain from donating sperm, during the treatment period and for at least 6 months after the final dose of oxaliplatin or gemcitabine, and 4 months after final dose of rituximab, obinutuzumab, glofitamab or tocilizumab to avoid exposing the embryo
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patient has failed only one prior line of therapy and is a candidate for
- •stem cell transplantation
- •Patient is a candidate for treatment with CAR T-cell therapy (only applicable in Germany and France)
- •Patient is a candidate for treatment with CAR-T cell therapy
- •History of transformation of indolent disease to DLBCL
- •High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by to 2016 WHO guidelines
- •Primary mediastinal B-cell lymphoma
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •Contraindication to obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
- •Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- •Prior treatment with R-GemOx or GemOx
- •Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) at enrollment
- •Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- •Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- •Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- •Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •Significant or extensive cardiovascular disease or significant pulmonary
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- •Diagnosis with SARS-CoV-2 infection within 30 days prior to the first study treatment, including asymptomatic SARS-CoV-2 infection
- •Documented SARS-CoV-2 infection within 6 months of first study treatment
- •Positive test results for hepatitis B virus infection and hepatitis C virus antibody
- •Known history of human immunodeficiency virus (HIV) seropositive status, known or suspected chronic active Epstein-Barr viral infection, hemophagocytic lymphohistiocytosis, history of progressive multifocal leukoencephalopathy
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
- •Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- •Prior solid organ transplantation; prior allogeneic stem cell transplant
- •Active autoimmune disease requiring treatment
- •Prior treatment with systemic immunosuppressive medications, within 4 weeks prior to first dose of study treatment
- •Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent.
- •Recent major surgery other than for diagnosis
- •Clinically significant history of cirrhotic liver disease
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment
研究者
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