EUCTR2020-004181-20-IT进行中（未招募）1 期
Camidanlumab tesirine (ADCT-301) in older classical Hodgkin lymphoma (cHL) patients with relapsed or refractory disease after front-line treatment or at high risk of failure, defined by a positive interim-PET (PET-2) after two cycles of first-line treatment: A phase II study - IEO1360
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
- •Histologically proven classical Hodgkin Lymphoma
- •Biopsy proven cHL in case of relapse or refractory disease after the end of first-line treatment; biopsy will not be required for patients with a positive PET after 2 cycles of front-line treatment
- •Age greater 60 years
- •Written informed consent
- •Eastern Cooperative Oncology Group (ECOG) Performance status <2
- •Relapse after < 12 months (early relapse) or Refractory disease defined as failure to achieve a CR after front-line treatment, or PET-2 positivity defined as PET-2 DS 4 or 5 after the first 2 cycles of front-line treatment
- •No more than 1 prior line of systemic chemotherapy ¿ radiation therapy
- •At least 3 weeks must have elapsed since the last administration of chemotherapy or radiation therapy
- •Bidimensional measurable disease based on the 2014 Lugano classification
- •FDG-avid disease by FDG-PET/CT
- •Patient with adequate organ function:
- •oAbsolute neutrophil count (ANC) = 1.0 x 103/¿L
- •oHaemoglobin = 7 g/dL
- •oPlatelets (PTL) = 75 x 103/¿L
- •oPatients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters.
- •oAST or ALAT = 2,5 x ULN (5 x ULN for those with lymphoma involvement of the liver
- •oBilirubin = 1.5 x ULN (except those with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL)
- •oCreatinine = 3 x ULN or creatinine clearance = 30 ml/min
- •CIRS-G < 10
- •Male patients, even if surgically sterilized, (i.e., status post vasectomy) and females, who have partners of childbearing potential, must agree to practice an adequate contraceptive method (hormonal or barrier method of birth control) during the entire study period and for 6 months following the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- •Life expectancy of greater than insert 3 months
- •Able to comply with study protocol
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Patients aged equal or less than 60 years
- •Patients with nodular lymphocyte-predominant HL
- •Any prior malignancy at other sites diagnosed or treated within 3 years before the first dose and/or evidence of residual disease, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix and adequately treated basal or squamous cell carcinoma of the skin.
- •Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
- •Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.
- •History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
- •History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
- •Patient who had major surgery less than 20 days before start of treatment
- •Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose. History of recent infection (within 4 weeks) considered to be caused by one of the following pathogens: SARS-CoV-2, HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, enterovirus D68. Patient presenting an uncontrolled infectious disease, including patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) and currently receiving antiretroviral therapy. Patients with active HBV infection defined by detection of HBs Ag positivity or active Hepatitis C (if antibody [Ab]+ then polymerase chain reaction [PCR]+) indicating acute or chronic infection will be excluded. However patients with viral load defined as negative could be included. Patients with prior history of hepatitis B infection, but immune, with only IgG hepatitis core antibody + (HBcAb+) must receive anti-viral prophylaxis (e.g., lamivudine 100mg po daily) for at least 1 week prior to the first dose of ADCT-301 and throughout all treatment and for at least 12 months after the last ADCT-301 dose.
- •Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.
- •Patients with dementia or an altered mental state or past psychiatric conditions that would preclude the understanding and rendering of informed consent and with the ability to comply with the study protocol
- •Known history of any of the following cardiovascular conditions
- •oMyocardial infarction within 3 months of enrollment
- •oNew York Heart Association (NYHA) Class III or IV heart failure
- •oEvidence of current severe uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities, including congenital long QT syndrome, or a corrected QTc interval of = 480 ms, at screening unless secondary to pacemaker or bundle branch block
研究者
相似试验
进行中（未招募）
不适用
Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality riskAcute myeloid leukemia and high risk myelodysplasiaEUCTR2015-004896-60-NLeiden University Medical Center
已完成
2 期
Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality riskmyelodysplasia10024324acute leukemiaNL-OMON42455eids Universitair Medisch Centrum19
尚未招募
不适用
Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality riskAcute myeloid leukemia (AML), Myelodysplasia (MDS), Acute myeloide leukemie, Myelodysplasie, Chemotherapy, ChemotherapieNL-OMON23606eiden University Medical Center (LUMC)20
招募中
1 期
Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy: a phase II study in BTKi-treated (or BTKi intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) patientsMantle cell lymphomaCTIS2024-511633-35-00Fondazione Italiana Linfomi Ets49
进行中（未招募）
1 期
oncastuximab tesirine administered as a consolidation treatment after immunochemotherapy in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL)Bruton Tyrosine Kinase inhibitors (BTKi) treated (or BTKi intolerant) relapsed/refractory (R/R) Mantle Cell Lymphoma (MCL).MedDRA version: 21.0Level: PTClassification code 10026800Term: Mantle cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-000715-23-ITFONDAZIONE ITALIANA LINFOMI ONLUS56