EUCTR2020-003999-40-IT进行中（未招募）1 期
A global multicenter phase 1/2 trial of EO2463, a novel microbial-derivedpeptide therapeutic vaccine, as monotherapy, and in combination withlenalidomide and rituximab, for treatment of patients with indolent NonHodgkin's Lymphoma. - SIDNEY
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ENTEROME
- 入组人数
- 54
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. Cohorts 1 and 4 patients should have relapsed/refractory, biopsyproven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and
- •have received at least one prior line of treatment (no limitation in
- •number of prior treatments; radiotherapy by itself is not considered a
- •treatment).
- •2. Cohort 2 patients should have newly diagnosed, previously untreated
- •(non-definitive radiotherapy as only prior treatment is allowed),
- •biopsyproven grade 1, 2 or 3A, FL or MZL, Ann Arbor stage III or IV, or Ann
- •Arbor stage I or II when the patient is not eligible for definitive
- •radiotherapy, ECOG performance status 0 or 1, and not be in need of
- •standard of care therapy according to the assessment of the treating
- •3. Cohort 3 patients should have newly diagnosed, previously untreated
- •(radiotherapy as only prior treatment is allowed), biopsy-proven grade
- •1, 2 or 3A, FL or MZL, Ann Arbor stage III or IV, ECOG performance
- •status 0 or 1, low tumor burden by GELF criteria (low tumor burden
- •defined as: no mass > 7 cm, < three masses >3 cm, no systemic or
- •Bsymptoms, no splenomegaly > 16 cm by PET/CT or CT scan, no risk of
- •vital organ compression, no leukemic phase > 5,000/µL circulating
- •lymphocytes, and no cytopenia [defined as platelets < 100,000/µL,
- •hemoglobin < 10 g/dL, or absolute neutrophil count <1,500/µL]), and
- •be in need of therapy according to the assessment of the treating
- •* MZL includes the entities extranodal MZL (EMZL, i.e. MALT lymphoma),
- •splenic MZL (SMZL), and nodal MZL
- •4. Patients with an age = 18 years
- •5. Patients who are human leukocyte antigen (HLA)-A2
- •6. Patients should have radiologically measurable disease with a lymph
- •node or tumor mass greater than or equal to 1.5 cm in at least one
- •Insufficient space, refer to the 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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients treated with dexamethasone > 2 mg/day or equivalent (ie 13
- •mg/day of prednisone or 53 mg/day of hydrocortisone) within 14 days
- •before the first EO2463 administration.
- •2. Patients with grade 3B FL or transformation to an aggressive
- •lymphoma subtype.
- •3. Patients with only one prior treatment and a high-risk profile as
- •defined by first progression of disease within 24 months of diagnosis
- •(the exclusion is not applicable for patients with more than one prior line
- •treatment).
- •4. Patients with prior exposure to EO2463.
- •5. Patients treated with immunotherapy (meaning immunostimulatory or
- •immunosuppressive therapy; beside excluded, or allowed, compounds
- •per other inclusion/exclusion criteria specifications), radionuclide
- •therapy, radiotherapy, cytoreductive therapy, or received treatment with
- •any other investigational agent within 28 days before the first EO2463
- •administration.
- •6. Patients to be included in Cohorts 1 and 4, and who have received
- •rituximab or other B cell ablation therapy within 8 weeks of start of
- •study treatment.
- •7. Patients to be included in Cohorts 1 and 4, and who have already
- •progressed during prior treatment with the R^2-regimen, i.e. an
- •adequate combination of lenalidomide and rituximab.
- •8. Patients with abnormal laboratory values according to the following
- •list (note, lab ranges according to the performing laboratory's reference
- •a. hemoglobin < 8 g/dL (sample should be taken = 7 days after any red
- •blood cell transfusion),
- •b. absolute neutrophil count decrease (< 1.0 ×10^9 /L) (sample should
- •be taken = 7 days after any growth factor administration),
- •c. platelet count decrease (< 75 ×10^9 /L) (sample should be taken = 7
- •days after any platelet transfusion),
- •d. bilirubin > 1.5 x upper limit of normal (ULN) (benign hereditary
- •hyperbilirubinemia, e.g. Gilbert's syndrome is permitted),
- •e. alanine aminotransferase (ALT) > 3 x ULN; if disease affecting the
- •liver > 5 x ULN,
- •f. aspartate aminotransferase (AST) > 3 x ULN; if disease affecting the
- •liver > 5 x ULN, and
- •g. serum creatinine increase (> 1.5 x ULN).
- •Insufficient space, refer to the Protocol.
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