Cumulative exposure to Fludarabine in patients undergoing reduced intensity allogeneic stem cell transplantation in Belgium

Phase 1

• Conditions: Patients undergoing allogeneic HSCT, for hematological malignancy, following RIC with Fludarabine, Melphalan and ATG.; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-503723-26-00
• Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified