2024-513252-15-00招募中2 期
KILT - A RANDOMIZED NON COMPARATIVE PHASE II STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX ALONE IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- LYSARC
- 入组人数
- 56
- 试验地点
- 57
- 主要终点
- modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause.
研究概览
简要总结
To evaluate the median modified progression-free survival (mPFS) of Lacutamab in patients treated with Gemcitabine-oxaliplatin (GemOx) at relapse followed by a Lacutamab maintenance, in relapsed/refractory (R/R) patients with KIR3DL2 positive PTCL-NOS, PTCL-TFH (including AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), ALCL, ATL, HSTL, EATL, MEITL, NKT and ANKL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •KIR3DL2-positive with at least 1% of tumor cells positivity, before randomization, based on central evaluation by IHC
- •ECOG performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization
- •Minimum life expectancy of 3 months
- •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 treatment
- •FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1
- •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
- •Patient covered by any social security system (France)
- •Patient who understands and speaks one of the country official languages
- •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) ALCL ATL: acute- or lymphoma-type HSTL EATL MEITL NKT ANKL
- •For patients with ALCL: previously treated with brentuximab vedotin
- •Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no mandatory latency after the previous treatment)
- •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)
- •Bi-dimensionally measurable disease defined by at least one single node or tumor lesion ≥ 1.5 cm assessed by CT scan
- •Signed written screening informed consent prior to KIR3DL2 screening
- •Signed written study informed consent prior to randomization
- •Aged 18 years or more with no upper age limit, at randomization
排除标准
- •Patients with active COVID-19 infection (last positive PCR < 2 weeks before randomization)
- •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
- •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
- •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
- •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
- •Major surgery within 4 weeks before randomization
- •Pregnant or lactating females
- •Person deprived of his/her liberty by a judicial or administrative decision
- •Person hospitalized without consent
- •Adult person under legal protection
- •Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
- •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))
- •Extensive radiotherapy (e.g. whole pelvis, half spine) within 3 months before randomization
- •Previous treatment by Gemcitabine or Oxaliplatin
- •Use of any experimental anti-cancer drug therapy within 6 weeks before randomization
- •Contraindication to any drug contained in the study treatment regimen
- •Previous allogenic hematopoietic cell transplantation
- •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)
- •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)
- •Central nervous system or meningeal involvement by lymphoma
结局指标
主要结局
modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause.
modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause.
次要结局
- Response rates according to Lugano classification PET-based
- Response rate assessed by Deauville criteria
- Duration Of Response (DOR)
- CR rate and ORR according to Lugano 2014 criteria (PET-based)
- subgroup analyses of mPFS, ORR, DOR, OS by PTCL subtype based on previous treatment lines
- rate of patients proceeding to allogenic stem cell transplantation
研究者
Anne VIOLA
Scientific
LYSARC
研究点 (57)
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