EUCTR2020-003735-16-FR招募中1 期
A RANDOMIZED NON COMPARATIVE PHASE II STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX ALONE IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA - KILT
YSARC0 个研究点目标入组 56 人开始时间: 2021年4月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central
- •evaluation by IHC
- •2. Patients with histologically documented PTCL
- •3. Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no
- •mandatory latency after the previous treatment)
- •4. With a maximum of 2 prior lines of systemic therapies, including autologous stem cell transplantation
- •5. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion = 1.5 cm assessed
- •6. Signed written screening informed consent prior to KIR3DL2 screening
- •7. Signed written study informed consent prior to randomization
- •8. Aged 18 years or more with no upper age limit, at randomization
- •9. ECOG performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization
- •10. Minimum life expectancy of 3 months
- •11. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method* from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments
- •12. FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1
- •13. Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal method for partners) from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •1. Patients with active COVID-19 infection (last positive PCR < 2 weeks before randomization)
- •2. Patients taking immunotherapy or chemotherapy, except short-term corticosteroids in monotherapy at a cumulated dose equivalent of prednisone = 1mg/kg/day, during 7 consecutive days, within 3 weeks prior to first administration of study drug (C1D1); or prephase treatment given at investigator’s discretion before randomization and for maximum 3 weeks (glucocorticosteroids, vepeside (VP16), cyclophosphamide, vincristine and
- •prednisone = 1mg/kg/day (COP))
- •3. Previous treatment by Gemcitabine or Oxaliplatin
- •4. Use of any experimental anti-cancer drug therapy within 6 weeks before randomization
- •5. Contraindication to any drug contained in the study treatment regimen
- •6. Positive test results for HIV and HCV
- •7. Known active hepatitis B (positive Ag HBs)
- •8. Central nervous system or meningeal involvement by lymphoma
- •9. Any of the following laboratory abnormalities prior randomization:
- •o Absolute neutrophil count (ANC) < 1 G/L, unless neutropenia is related to PTCL
- •o Platelet count < 75 G/L, unless thrombopenia is related to PTCL
- •o Alkaline Phosphatases > 2.5 x upper limit of normal (ULN)
- •o Serum SGOT/AST or SGPT/ALT > 2.5 x ULN
- •o Bilirubin > 1.5 x ULN, unless SGOT/AST and SGPT/ALT > 2.5 x ULN or
- •bilirubin elevated due to PTCL or hemolysis
- •o Calculated creatinine clearance (MDRD or Cockroft) < 40 mL/min
- •10. Any significant cardiovascular impairment: uncontrolled high blood pressure, unstable angina, myocardial infarction or stroke within the last 6 months from randomization, and cardiac arrhythmia within the last 3 months from randomization
- •11. Uncontrolled clinically significant intercurrent illness including, but not limited to, diabetes, ongoing active infections. Patients receiving antibiotics for infections that are under control may be included in the study
- •12. Concurrent malignancy or prior history of malignancies other than lymphoma unless the subject has been free of disease for = 2 years, except early stage cutaneous squamous or basal cell carcinoma, localized prostate cancer, or cervical intraepithelial neoplasia
- •13. Major surgery within 4 weeks before randomization
- •14. Pregnant or lactating females
研究者
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