EUCTR2020-003735-16-DE进行中（未招募）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: 2023年2月1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
- 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:
- •o Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at relapse is recommended but not mandatory):
- •? PTCL-NOS
- •? PTCL-TFH (AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype)
- •? ATL: acute- or lymphoma-type
- •3. For patients with ALCL: previously treated with brentuximab vedotin
- •4. Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no mandatory latency after the previous treatment)
- •5. With a maximum of 2 prior lines of systemic therapies, including autologous stem cell transplantation (ASCT is authorized in first and second line and is not comptabilized as a unique line, even if associated to a systemic therapy)
- •6. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion = 1.5 cm assessed by CT scan
- •7. Signed written screening informed consent prior to KIR3DL2 screening
- •8. Signed written study informed consent prior to randomization
- •9. Aged 18 years or more with no upper age limit, at randomization
- •10. ECOG performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization
- •11. Minimum life expectancy of 3 months
- •12. 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 6 months after the last study treatments
- •13. FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1
- •14. Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal
- •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 (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. Previous allogenic hematopoietic cell transplantation
- •7. Positive test results for HIV and HCV (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)
- •8. Known active hepatitis B (positive Ag HBs) (if latent HBV (positive anti-HBc), patients have to be treated with Entecavir (Baraclude ®) and HBV PCR should be performed every month to allow antiviral strategy adapatation)
- •9. Central nervous system or meningeal involvement by lymphoma
- •10. 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
- •11. Any significant cardiovascular impairment: New York Heart Association (NYHA) Class III or IV cardiac disease, 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
- •12. 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
- •13. 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
- •14. Major surgery within 4 weeks before randomization
- •15. Pregnant or lactating females
- •16. Person deprived of his/her liberty by a judicial or administrative decision
- •17. Person hospitalized without consent
- •18. Adult person under legal protection
- •19. Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
- •20.Extensive radiotherapy (e.g. whole pelvis, half spine) within 3 months before randomization
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