EUCTR2014-003418-10-IT进行中（未招募）1 期
PEPTIDE RECEPTOR RADIONUCLIDE THERAPY WITH 90Y-DOTATOC IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL AND MANTLE CELL LYMPHOMAS
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS0 个研究点目标入组 35 人开始时间: 2014年9月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •1. Male or Female, aged >18 years.
- •2 . Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments.
- •3. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT with 68Ga-DOTATOC images demonstrate a significant uptake in the tumour (SSR-positive tumour).
- •4.Patients must have at least one bidimensional measurable lesion with long axis > 15 mm at CT scan (MRI is allowed only if CT scan cannot be performed), according to Cheson Criteria [48].
- •5.ECOG performance status = 2.
- •6.Life expectancy of at least 3 months.
- •7.Adequate cardiac function (EF >50%) as assessed at echocardiography and ECG.
- •8.Conserved hematological, liver and renal parameters, and in particular: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin =1.5 X UNL (upper normal limit), ALT <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL
- •9.Patients must not have received other treatments with radiopeptides (e.g. 111In-pentetreotide, 177Lu-DOTATATE, 131I-MIBG).
- •10. If female of childbearing potential, agreement to use adequate contraceptive
- •methods (e.g., oral contraceptives, condoms, or other adequate barrier
- •controls, intrauterine contraceptive devices, or sterilization) beginning at
- •screening visit and continuing until 3 months following last treatment with study
- •drug. Negative serum pregnancy test for females of childbearing potential within 7
- •days of starting treatment.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1.Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
- •2.Bone marrow invasion > 25 %.
- •3.Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers); subjects must be
- •free from other neoplasms at least 3 years.
- •All acute toxic effects of any prior therapy (including surgery radiation therapy,chemotherapy) must have resolved
- •to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version
- •4.0 (CTCAE).
- •4.Evidence of myelodysplastic syndrome or other hematologic diseases
- •5.Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks.
- •6.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •7.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive
- •heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit
- •compliance with study requirements.
- •8.Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HbsAg). In addition,
- •if negative for HBsAg but Hepatits B core antibody (HBcAb) positive (regardless of HBsAb status), a HBV DNA test
- •will be performed and if positive the subject will be excluded.
- •Any patient with HBcAb positivity will receive anti viral prophylaxis during the study, according to the procedures
- •suggested by local Hepatology service.
- •9.History of allergic reactions attributed to compounds of similar chemical or biologic composition.
- •10.Previous autologous stem cell transplant in the last 2 months.
研究者
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