EUCTR2014-005382-79-IT进行中（未招募）1 期
A phase II study with bendamustine plus brentuximab vedotin in Hodgkin’s lymphoma and CD30 + peripheral T-cell lymphoma in first salvage setting: the BBV regimen. - FIL-BBV
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 65 人开始时间: 2021年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •4.1. Inclusion criteria for patients with classical Hodgkin’s lymphoma
- •1) Patients at first relapse or with primary refractory disease (i.e. patients who have previously
- •received only 1 line of treatment). Patients must have completed any prior treatment with
- •radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at
- •least 4 weeks prior to the first BBV dose
- •2) Histologically-confirmed CD30+ disease (IHC BerH2 antibody)
- •3) Age from 18 to 60 years.
- •4) Fluorodeoxyglucose (FDG)-avid and measurable disease (lymph nodes must have long axis
- •of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 and short axis > 1.0 cm) as
- •documented by both PET and CT.
- •5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6) The following required baseline laboratory data: absolute neutrophil count (ANC) =
- •1500/µL, unless known marrow involvement due to disease, platelets = 75,000/µL, unless
- •known marrow involvement due to disease, bilirubin = 1.5 x upper limit of normal (ULN) or
- •= 3 x ULN for patients with Gilbert’s disease, serum creatinine = 1.5 X ULN, alanine
- •aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 X ULN.
- •7) Serum Albumin = 3 g/dL.
- •8) Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy
- •test result within 7 days prior to the first dose of therapy. Females of non-childbearing
- •potential are those who are postmenopausal for more than 1 year or who have had a bilateral
- •tubal ligation or hysterectomy.
- •9) Both females of childbearing potential and males who have partners of childbearing
- •potential must agree to use an effective contraceptive method during the study and for at
- •least 6 months following the last dose of study drug.
- •10) Male patients, even if surgically sterilized (i.e., post vasectomy), who:
- •Agree to practice effective barrier contraception during the entire study treatment
- •period and through 6 months after the last dose of the study drug, or
- •Agree to completely abstain from heterosexual intercourse
- •11) Patients must provide written informed consent.
- •4.3. Inclusion criteria for patients with peripheral T-cell lymphomas
- •1) Patients with refractory or relapsed PTCL regardless of the number of prior therapy lines.
- •Patients must have completed any prior treatment with radiation, chemotherapy, biologics,
- •immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of
- •2) Signed written informed consent.
- •3) Age from 18 to 60 years.
- •4) Histologically confirmed diagnosis of PTCL, i.e. PTCL-not otherwise specified (PTCLNOS),
- •angioimmunoblastic T cell lymphoma (AITL) and transformed mycosis fungoides
- •according to the World Health Organization (WHO) 2008 classification.
- •5) Histologically confirmed CD30+ PTCL (IHC BerH2 antibody).
- •6) Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at study
- •7) At least one site of measurable disease in two dimensions by computed tomography. Both
- •nodal and extranodal sites will be taken into consideration (lymph nodes must have long
- •axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis > 1.0 cm).
- •8) Hematology values within the following limits:
- •a. absolute neutrophil count (ANC) = 1500/mm3 independent of growth factor support;
- •b. platelets = 75,000/mm3 or = 50,000/mm3 if bone marrow involvement is independent
- •of transfusion support;
- •c. hemoglobin level = 8 g/dL.
- •9) Biochemical values within the following limits:
排除标准
- •4.2. Exclusion criteria for patients with classical Hodgkin’s lymphoma
- •1) Previous treatment with bendamustine or brentuximab vedotin.
- •2) Prior autologous stem cell transplant.
- •3) Known history of any of the following cardiovascular conditions: myocardial infarction
- •within 2 years of study entry; NYHA class III or IV heart failure; cardiac arrhythmias;
- •angina; any electrocardiographic evidence of acute ischemia or conduction system
- •abnormalities; recent evidence (within 6 months before the first dose of study drug) of a leftventricular ejection fraction < 50%.
- •4) History of another primary malignancy for within 3 years of study entry (the following are
- •exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized
- •prostate cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion
- •on PAP smear).
- •5) Known cerebral/meningeal disease (HL or any other etiology) or testicular involvement.
- •6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
- •7) Pre-existing Peripheral Neuropathy = 2.
- •8) Any active systemic viral, bacterial, or fungal infection requiring treatment with
- •antimicrobial therapy within 2 weeks prior to the first dose of therapy.
- •9) Current therapy with other systemic anti-neoplastic or investigational agents.
- •10) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent
- •within 1 week prior to the first dose of therapy.
- •11)Women who are pregnant or breastfeeding.
- •12) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any
- •excipient contained in the drug formulation of brentuximab vedotin and to bendamustine.
- •13)Known human immunodeficiency virus (HIV) positivity.
- •14)Known hepatitis B surface antigen (HBsAg) positivity or known or suspected active
- •hepatitis C infection.
- •15) Patients with dementia or altered mental state that would preclude the understanding and
- •rendering of informed consent.
- •4.4. Exclusion criteria for patients with peripheral T-cell lymphomas
- •1) Diagnosis of cutaneous T-cell lymphoma, anaplastic large-cell lymphoma (ALCL), mycosis
- •fungoides or Sézary Syndrome.
- •2) Previous treatment with bendamustine or brentuximab vedotin.
- •3) Prior autologous stem cell transplant.
- •4) Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
- •contained in the drug formulation of brentuximab vedotin and to bendamustine.
- •5) Any serious active disease or co-morbid medical condition (according to investigator's
- •6) Prior history of malignancies other than lymphoma (except for a history of a complete
- •resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the
- •cervix or breast) unless the subject has been free of the disease for = 3 years.
- •7) Pre-existing peripheral neuropathy grade = 2.
- •8) Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
- •9) Any serious medical condition, laboratory abnormality, or psychiatric illness that would
- •prevent the subject from signing the informed consent form.
- •10) Pregnant or lactating females or men or women of childbearing potential not willing to use
- •an adequate method of birth control for the duration of the study or a positive pregnancy test
- •on day 1 before first dose of study drug.
- •11) Central nervous system disease (meningeal and/or brain involvement by lymphoma) or
- •testicular involvement.
- •12)History of clinically relevant liver or renal insufficiency; significant pulmonary,
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