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Cumulative exposure to Fludarabine in patients undergoing reduced intensity allogeneic stem cell transplantation in Belgium
EU CTIS ID: 2023-503723-26-00
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.