EUCTR2021-000870-27-DK进行中（未招募）1 期
A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL) - CAPITA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
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
- •- Patient must be = 18 years of age, at the time of signing the informed consent
- •- ECOG performance status = 2
- •- Life expectancy > 6 months
- •- Female patients must not be breast-feeding and must have a negative pregnancy test prior to start of dosing
- •Additional core inclusion criteria may apply, please refer to the protocol.
- •Module 1 specific inclusion criteria:
- •Additional Inclusion Criteria for Cohort 1A (R/R FL):
- •- Histologically confirmed diagnosis of FL Grade 1, 2, or 3a as assessed by investigator or local pathologist
- •- Current need for systemic treatment based on the Investigator’s opinion
- •- Relapsed, progressed or refractory (defined as failure to achieve at
- •least a PR) after at least 2 prior systemic lines of therapy (including anti-
- •D20mAb and an alkylating agent). The treating physician should
- •discuss with the patient all available treatment options, including the
- •use of CAR-T cell therapy, evaluating benefits and risks before
- •considering enrolment in this study.
- •- Bi-dimensionally measurable disease on cross sectional imaging by CT
- •or MRI with at least one nodal lesion > 1.5 cm in the long axis or at least
- •one extranodal lesion > 1 cm in long axis.
- •Additional Inclusion Criteria for Cohort 1B (R/R MZL):
- •- Histologically confirmed MZL including splenic, nodal, and extranodal
- •subtypes as assessed by investigator or local pathologist.
- •- Current need for systemic treatment based on the Investigator's
- •- Relapsed, progressed or refractory (defined as failure to achieve at
- •least a PR) after at least 2 prior systemic lines of therapy (including at
- •least one anti-CD20mAb directed regimen either as monotherapy or as
- •chemoimmunotherapy; Helicobacter pylori eradication and radiation
- •therapy alone will not be considered a systemic treatment regimen).
- •- Bi-dimensionally measurable disease on cross sectional imaging by CT
- •or MRI with at least one nodal lesion > 1.5 cm in the long axis or at least
- •one extranodal lesion > 1 cm in long axis.
- •Additional Inclusion Criteria for Cohort 1C (R/R MCL):
- •- Histologically confirmed MCL, with documentation of monoclonal B cells
- •that have a chromosome translocation t(11;14)(q13;q32) and/or
- •overexpress cyclin D1, as assessed by investigator or local pathologist.
- •- Relapsed, progressed or refractory (defined as failure to achieve at
- •least a PR) after at least 2 prior systemic lines of therapy.
- •- Patients must have received as prior therapies:
- •a) BTK inhibitor and
- •b) Anti-CD20 monoclonal antibody therapy
- •The treating physician should discuss with the patient all available
- •treatment options, including the use of CAR-T cell therapy, evaluating
- •benefits and risks before considering enrolment in this study.
- •- Bi-dimensionally measurable disease on cross sectional imaging by CT
- •or MRI with at least one nodal lesion > 1.5 cm in the long axis or at least
- •one extranodal lesion > 1 cm in long axis.
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- 另有 1 项未显示
排除标准
- •- Prior malignancy (other than the disease under study), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the patient has been disease free for = 2 years
- •- With the exception of alopecia, any unresolved non-haematological toxicities from prior therapy = CTCAE Grade 2 at the time of starting study treatment
- •- Known medically apparent CNS lymphoma or leptomeningeal disease
- •- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values at screening:
- •a) Absolute neutrophil count < 1.0 × 10^9/L; < 0.75 × 10^9/L in participants with known bone marrow involvement of malignant disease
- •b) Platelets < 75 × 10^9/L; < 50 × 10^9/L in participants with known bone marrow involvement of malignant disease
- •c) Creatinine clearance < 50 mL/min per the Cockcroft and Gault formula
- •- Clinically significant abnormalities of glucose metabolism as participants with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment OR Glycosylated haemoglobin = 8.0% (63.9 mmol/mol)
- •- Prior treatment with any of the following:
- •a) Any investigational agents or study drugs from a previous clinical study within 5 half lives or 2 weeks from the first dose of capivasertib in this study
- •b) Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to the
- •first dose of study treatment (3 weeks for St John's wort), or drugs that
- •are sensitive to inhibition of CYP3A4 within 1 week prior to the first dose
- •of study treatment.
- •c) Prior allogenic HSCT within 6 months from the first dose of
- •capivasertib (patients > 6 months after allogenic HSCT are eligible in the
- •absence of active graft-versus-host disease and concomitant immune
- •suppressive therapy). Prior cellular therapies (eg, CAR-T therapy)
- •and/or autologous HSCT within 3 months from the first dose of
- •capivasertib.
- •d) Receipt of live, attenuated vaccine within 28 days before the first
- •dose of study treatment(s).
- •e) Patients who, due to other medical conditions /prior history
- •/concomitant medications are, in the investigator's opinion, at a risk of a
- •VTE and are not willing to accept the VTE prophylaxis, will be excluded.
- •The initiation of an adequate VTE prophylaxis will be based on treating
- •physician risk/benefit assessment and in agreement with the local
- •management guidelines.
- •Additional exclusion core criteria may apply, please refer to the protocol
- •Module 1 specific exclusion criteria:
- •- Follicular lymphoma grade 3B.
- •- Known transformation to aggressive lymphoma, eg, large cell
- •- Patients who, in the Investigator's opinion, require immediate
- •cytoreductive therapy for disease control
研究者
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