2023-503723-26-00招募中4 期
Cumulative exposure to Fludarabine in patients undergoing reduced intensity allogeneic stem cell transplantation in Belgium
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Area under the curve (AUC) of F-Ara-A after exposure to Fludarabine in the context of reduced intensity conditioning with Fludarabine, Melphalan and anti-thymocyte globulin (ATG). To be assessed after the last included patient has finished conditioning regimen.
研究概览
简要总结
The cumulative exposure and interpatient variability in (cumulative) exposure to F-Ara-A in patients receiving reduced intensity conditioning (RIC) with standard dose Fludarabine based on body surface area (BSA).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-label, national, multicentre, prospective, phase 4, pharmacological trial.
- 盲法
- None
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
- •Age ≥ 18 years
- •Be able to understand and sign an informed consent
- •Hematological malignancy
- •Women of childbearing potential (WOCBP), defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal, and men who are sexually active must use a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for participants participating in clinical trials. Men must use a highly effective method of birth control and agree not to father a child or donate sperm during and after the study. For females, these restrictions apply for 6 months after chemotherapy/conditioning. For males, these restrictions apply for 6 months after chemotherapy/conditioning
- •Allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning regimen containing IV Fludarabine 30 mg/m² for 5 days, IV Melphalan 100 or 140 mg/m² in total and IV ATG (Thymoglobulin or Grafalon according to local standard protocol)
- •Use of Tacrolimus or Ciclosporin and Mycophenolate Mofetil (MMF) as graft versus host disease (GvHD) prevention
- •Human leukocyte antigen (HLA) identical sibling donor, 10/10 HLA matched unrelated donor or 9/10 mismatched unrelated donor
排除标准
- •Any condition not fulfilling inclusion criteria
- •Pregnancy or lactation
- •Known allergic reactions to components of the conditioning regimen (Fludarabine, Melphalan, ATG)
- •No other line available for blood sampling than the infusion line through which Fludarabine was administered (patients with a double or triple lumen central catheter will not be excluded as a second lumen is available for sampling) and patient unable or unwilling to undergo peripheral blood sampling
- •Patients on dialysis
- •Renal insufficiency with creatinine clearance < 30 ml/min
- •Acute or chronic active infection
- •Decompensated hemolytic anemia
结局指标
主要结局
Area under the curve (AUC) of F-Ara-A after exposure to Fludarabine in the context of reduced intensity conditioning with Fludarabine, Melphalan and anti-thymocyte globulin (ATG). To be assessed after the last included patient has finished conditioning regimen.
Area under the curve (AUC) of F-Ara-A after exposure to Fludarabine in the context of reduced intensity conditioning with Fludarabine, Melphalan and anti-thymocyte globulin (ATG). To be assessed after the last included patient has finished conditioning regimen.
次要结局
- Association between F-Ara-A AUC and creatinine clearance; To be assessed after the last included patient has finished conditioning regimen
- Association between F-Ara-A AUC and bodyweight/BMI; To be assessed after the last included patient has finished conditioning regimen.
- Influence of F-Ara-A AUC on non-relapse mortality, relapse rate, progression free survival and overall survival; To be assessed when: - the first 25 included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant. - all included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant.
- Influence of F-Ara-A AUC on median time to neutrophil and platelet engraftment; To be assessed when: - the first 25 included patients have reached 1 year of follow-up post-transplant. - all included patients have reached 1 year of follow-up post-transplant.
- Influence of F-Ara-A AUC on peripheral CD4 and CD8 T-cell count. To be assessed when: - the first 25 included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant. - all included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant.
- Influence of F-Ara-A AUC on incidence of central nervous system complications/events in the first year after allogeneic stem cell transplant.
- Applicability of pharmacokinetic model published by Langenhorst et al (6) on the study population to predict F-Ara-A AUC.
研究者
Anke Delie
Scientific
Universitair Ziekenhuis Gent
研究点 (3)
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