A Prospective Multicenter Phase 2 Study of the Chemotherapy-light Combination of Intravenous Rituximab With the Antibody-drug Conjugate Polatuzumab Vedotin and the Bispecific Antibody Glofitamab in Previously Untreated Aggressive B-cell Lymphoma Patients Above 60 Years of Age Ineligible for a Fully Dosed R-CHOP

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest35 个研究点分布在 2 个国家目标入组 125 人2023年3月20日

适应症Lymphoma, Large B-Cell, Diffuse

干预措施Glofitamab Rituximab Obinutuzumab Polatuzumab vedotin

概览

阶段: 2 期
干预措施: Glofitamab
疾病 / 适应症: Lymphoma, Large B-Cell, Diffuse
发起方: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
入组人数: 125
试验地点: 35
主要终点: 1 year progression-free survival (PFS) rate of the first 80 patients
状态: 进行中（未招募）
最后更新: 24天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

In the present trial the chemotherapy- light treatment concept R-Pola-Glo will be evaluated that combines the anti-CD20 antibody rituximab (R) with the ADC polatuzumab vedotin (Pola) and the (BiMabs) glofitamab (Glo) in elderly and/or medical unfit and previously untreated patients with aggressive B-cell lymphoma. The outcome and feasibility data obtained here will be used for further clinical development of this new chemolight triple combination.

注册库

clinicaltrials.gov

开始日期

2023年3月20日

结束日期

2028年2月28日

最后更新

24天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

责任方

Sponsor

入排标准

入选标准

•Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated treatments according to ICH and local regulations.
•Patient is above 60 years of age
•Patient is not eligible for a fully dosed R-CHOP
•Patient has histologically confirmed aggressive B-cell lymphoma.
•Patient has at least one measurable FDG PET-positive lymphoma manifestation; defined as lesional maximum FDG uptake higher than the maximum FDG uptake in unaffected liver parenchyma as measured in a reference volume-of-interest with \>10 mL
•Baseline biopsy material is available for central review.
•Female patients considered as women of childbearing potential (WOCBP, see section 5.2.7 for definition) and male patients with female partners considered as WOCBP must:
•agree to either remain completely abstinent (refrain from heterosexual intercourse) or to use at least one effective contraceptive methods that results in a failure rate of \< 1% per year
•refrain from donating ova (female patients) or donating sperm (male patients)
•in case of male patients with pregnant female partners, remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom to avoid exposing the embryo.

排除标准

•Medical conditions:
•Patient with chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) (including CD20+ ALL), lymphoblastic lymphoma, Richter's transformation, Burkitt lymphoma.
•Patient ≤ 60 years
•Patient with known active infection, or reactivation of a latent infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus \[EBV\], cytomegalovirus \[CMV\], hepatitis B, hepatitis C, and HIV\], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
•Patient with current \> Grade 1 peripheral neuropathy.
•Patient with history of confirmed progressive multifocal leukoencephalopathy (PML).
•Patient with history of leptomeningeal disease.
•Patient with current or history of CNS lymphoma.
•Patient with current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease with exceptions.
•Patient with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence), with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%), such as adequately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.

研究组 & 干预措施

chemolight R-Pola-Glo treatment

干预措施: Glofitamab

chemolight R-Pola-Glo treatment

干预措施: Rituximab

chemolight R-Pola-Glo treatment

干预措施: Obinutuzumab

chemolight R-Pola-Glo treatment

干预措施: Polatuzumab vedotin

结局指标

主要结局

1 year progression-free survival (PFS) rate of the first 80 patients

时间窗: 12 months

defined as the time from the day of inclusion until disease progression (PD) or relapse after complete remission (CR), or death due to any cause, whichever occurs first

次要结局

Response rate at different timepoints(6 weeks, 18 weeks, 36 weeks)
Relapse rate(54 months)
Event-free survival (EFS)(54 months)
Duration of response (DoR)(54 months)
Rate and type of adverse events (AEs) and serious adverse events (SAEs)(54 months)
Treatment-related death rate(54 months)
Rate of secondary malignancies(54 months)
Protocol adherence(54 months)
Patient-reported outcomes for quality of life (QoL): EORTC QLQ-C30(54 months)
Overall survival (OS)(54 months)
Conversion rate of PR to CR(54 months)
Patient-reported outcomes for quality of life (QoL): FACT-Lym(54 months)