2023-503423-25-00招募中3 期
HOVON 127 BL / SAKK 37/16: Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma
Haemato Oncology Foundation For Adults Netherlands11 个研究点 分布在 2 个国家目标入组 69 人开始时间: 2024年9月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 11
- 主要终点
- 2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive
研究概览
简要总结
To confirm in a multicenter setting an improvement in PFS to 85% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected PFS of 70% at 2 years for the control arm R-CODOX-M/R-IVAC
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
- 是
入选标准
- •First diagnosis of high risk Burkitt lymphoma (sporadic and HIV associated), histologically confirmed according to the WHO classification
- •Upon its availability the WHO 2016 classification should be used, to replace the WHO 2008 classification
- •High risk disease; i.e. any of following: elevated LDH, WHO performance status ≥ 2 (appendix C), Ann Arbor stage III or IV (Appendix A), tumour mass ≥ 10 cm
- •Age 18-75 years inclusive
- •WHO performance status (PS) 0-3, WHO PS 4 only if disease related (Appendix C)
- •Written informed consent
排除标准
- •All histopathological diagnoses other than Burkitt lymphoma according to the WHO classification 2008, irrespective of the presence of a MYC rearrangement; Upon its availability the WHO 2016 classification should be used, to replace the WHO 2008 classification
- •Severe neurological or psychiatric disease
- •Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If an ultrasound or MUGA scan is obtained the LVEF should exceed 45%
- •All men and all women of child-bearing potential not willing or able to use an acceptable method of birth control for the duration of the study and one year beyond treatment completion
- •Female subject pregnant or breast-feeding
- •History of a prior invasive malignancy in the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- •Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety, includig active hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection
- •Current participation in another clinical trial interfering with HO127
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Patients with endemic Burkitt lymphoma
- •Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH, WHO performance status 0 or 1 (appendix C), Ann Arbor stage I or II (Appendix A), no tumour mass ≥ 10 cm)
- •Patients with CNS localization of Burkitt lymphoma
- •Prior treatment other than local radiation (max. 10 Gy) or short course (max 7 days) of steroids ≤ 1 mg/kg or ≤100mg predniso(lo)ne (whichever is greater; or equivalent corticosteroid) or acute symptoms; or 1 cycle of R-CHOP
- •Creatinine clearance < 50 ml/min unless lymphoma related
- •Inadequate hepatic function: bilirubin > 2.5 * ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated
- •Inadequate haematological function ANC < 1x10^9/l and platelets < 75x10^9 /l unless lymphoma related
- •Severe pulmonary dysfunction (CTCAE grade 3-4, see Appendix D)
结局指标
主要结局
2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive
2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive
次要结局
- ORR end-of-treatment
- EFS at 2 years; defined as time from randomisation to first event (death from any cause, no CR, relapse, whichever comes first).
- OS at 2 years; defined as time from randomisation until death from any cause; patients still alive or lost to follow up are censored at the date they were last known to be alive
- Rate of CTCAE grade ≥3 toxicities
- Number of hospitalization days
研究者
M.E.D. Chamuleau
Scientific
Haemato Oncology Foundation For Adults Netherlands
研究点 (11)
Loading locations...
相似试验
招募中
3 期
A study to learn more about how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations of the human epidermal growth factor receptor 2 (HER2)2024-511319-91-00Bayer AG145
招募中
1 期
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D MutationNCT07259590Genfleet Therapeutics (Shanghai) Inc.126
已完成
1 期
Phase 1b study to evaluate MK 0482 for Relapsed/Refractory AML/CMML2023-503580-42-00Merck Sharp & Dohme LLC15
招募中
3 期
Extension Study for Participants in Studies That Include Pembrolizumab2022-501254-10-00Merck Sharp & Dohme LLC1,133
招募中
3 期
A study to evaluate the efficacy and safety of Clascoterone solution in treatment of male pattern hair loss.Androgenetic Alopecia2023-504421-39-00Cassiopea S.p.A.629