KCT0012253进行中（未招募）2 期
A PROSPECTIVE PHASE 2 STUDY OF THE COMBINATION OF POLATUZUMAB VEDOTIN AND GLOFITAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITHIN 12 MONTHS OF R-CHOP TREATMENT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- All
入选标准
- •1.Histologically proven DLBCL
- •2.Relapsed or refractory disease after first-line chemoimmunotherapy containing both rituximab and anthracycline
- •A.Refractory disease defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded
- •Progressive disease (PD) as best response to first-line therapy
- •Stable disease (SD) as best response after at least 4 cycles of first-line therapy
- •Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
- •B.Relapsed disease defined as complete remission to first-line therapy followed by biopsy- proven disease relapse = 12 months of initiating first-line therapy
- •3.Signed written Informed Consent Form
- •4.Age = 19 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- •5.Life expectancy = 12 weeks
- •6.Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- •7.At least one bi-dimensionally measurable (= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (= 1 cm) extranodal lesion, as measured on CT scan
- •8.Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 7 days prior to enrollment
- •9.Negative HIV test at screening, with the following exception:
- •i.Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count = 200/µL, and have an undetectable viral load.
- •10.For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined below:
- •i.Female participants must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 18 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 9 months after the final dose of polatuzumab vedotin, and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period
- •ii.A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- •iii.Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •Hormonal contraceptive methods must be supplemented by a barrier method.
- •iv.The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contr
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •1.Prior solid organ transplantation
- •2.Prior treatment with a regimen containing polatuzumab vedotin or glofitamab
- •3.Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter
- •4.Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
- •5.Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
- •6.Prior radiotherapy to the mediastinal/pericardial region(Radiotherapy to non-target lesion sites will be permitted.)
- •7.Current Grade > 1 peripheral neuropathy
- •8.Corticosteroid use > 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
- •i.Participants receiving corticosteroid treatment with = 50 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle
- •Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted
- •The use of inhaled corticosteroids is permitted.
- •The use of mineralocorticoids for management of orthostatic hypotension is permitted.
- •The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.
- •ii.Participants who require lymphoma symptom control during screening may receive steroids in the following manner:
- •Up to 50 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).
- •If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of > 30–100 mg/day of prednisone or equivalent. Prednisone > 30–100 mg/day or equivalent may be given for a maximum of 10–14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered.
- •9.History of other malignancy that could affect compliance with the protocol or interpretation of results:
- •i.Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.
- •ii.Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for = 2 years prior to enrollment are eligible.
- •iii.Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.
- •10.Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 mon
研究者
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