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Study on Fludarabine, Melphalan, and ATG for Patients with Blood Cancer Undergoing Reduced Intensity Stem Cell Transplantation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with hematological malignancies, which are types of blood cancers. The study involves patients who are undergoing a procedure called allogeneic hematopoietic stem cell transplantation (HSCT) with a reduced intensity conditioning regimen. This regimen includes the use of medications such as Fludarabine, Melphalan, and anti-thymocyte globulin (ATG), which help prepare the body for the transplant. The purpose of the study is to understand how patients are exposed to a component of Fludarabine, known as F-Ara-A, during this treatment process.

Participants in the study will receive these medications intravenously, meaning they are given directly into a vein. The study will monitor the cumulative exposure to F-Ara-A, which means the total amount of this substance that the body is exposed to over time. The study will also look at how this exposure varies between different patients. This information will help researchers understand how the body processes these medications and how this might affect the outcomes of the transplant.

The study will follow patients over a period of time to observe various outcomes, such as survival rates and the body's ability to recover blood cell counts after the transplant. Researchers will also examine how factors like body weight and kidney function might influence the levels of F-Ara-A in the body. This trial aims to gather important data that could improve the treatment process for patients undergoing stem cell transplants in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, understanding of the study, and specific medical conditions.
Participants must agree to use effective birth control methods during and after the study.
Step 2
Preparation for treatment
Participants undergo a reduced intensity conditioning regimen in preparation for stem cell transplantation.
This involves the administration of Fludarabine, Melphalan, and anti-thymocyte globulin (ATG) intravenously.
Step 3
Medication administration
Receive Fludarabine at a dose of 30 mg/m² intravenously for 5 days.
Receive Melphalan at a total dose of 100 or 140 mg/m² intravenously.
Receive ATG (either Thymoglobulin or Grafalon) according to the local standard protocol.
Step 4
Graft versus host disease prevention
Use of Tacrolimus or Ciclosporin and Mycophenolate Mofetil (MMF) to prevent graft versus host disease.
Step 5
Post-treatment monitoring
Monitoring of the area under the curve (AUC) of F-Ara-A, a component of Fludarabine, to assess exposure levels.
Evaluation of associations between F-Ara-A AUC and factors such as creatinine clearance, body weight, and body mass index (BMI).
Step 6
Follow-up assessments
Assessment of the influence of F-Ara-A AUC on outcomes like non-relapse mortality, relapse rate, progression-free survival, and overall survival.
Monitoring of neutrophil and platelet engraftment times, peripheral CD4 and CD8 T-cell counts, and incidence of central nervous system complications.
Step 7
Long-term follow-up
Participants are followed up for 1, 2, and 3 years post-transplant to evaluate long-term outcomes.
The study is estimated to conclude by July 2029.

Who can join the trial?

7 criteria

Must be **18 years or older**.
Must be able to **understand and sign** a document that explains the study and agrees to participate.
Must have a **hematological malignancy**, which means a type of cancer that affects the blood, bone marrow, or lymph nodes.
Women who can have children and men who are sexually active must use a **highly effective method of birth control** during and after the study. This is to prevent pregnancy. For women, this applies for **6 months** after treatment. For men, this also applies for **6 months** after treatment.
Must be undergoing a specific type of **stem cell transplantation** called allogeneic hematopoietic stem cell transplantation with a reduced intensity conditioning regimen. This includes receiving certain medications: **Fludarabine**, **Melphalan**, and **ATG**.
Must use **Tacrolimus or Ciclosporin** and **Mycophenolate Mofetil (MMF)** to prevent a condition called graft versus host disease (GvHD), which can occur after a transplant.
Must have a **donor** who is either a sibling with the same human leukocyte antigen (HLA) type, a completely matched unrelated donor, or a nearly matched unrelated donor.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Az St-Jan Brugge-Oostende A.V.
Brugge, Belgium
Verified
Centre hospitalier universitaire de Liege
Liege, Belgium
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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Fludarabine is a medication used in this clinical trial for patients undergoing a type of stem cell transplant called reduced intensity allogeneic stem cell transplantation. It is used as part of the conditioning process before the transplant. The goal is to prepare the patient's body to accept the new stem cells. Fludarabine works by interfering with the growth of cancer cells, which are then destroyed by the body. In this trial, the focus is on understanding how much of the medication patients are exposed to and how this exposure varies between different patients.

What is already known about the treatment

Fludarabine – Fludarabine is administered intravenously and is used in the treatment of certain blood cancers, particularly in patients undergoing reduced intensity conditioning for allogeneic stem cell transplantation. It is currently well-documented in medical literature as a chemotherapy agent. The main therapeutic indication is for hematological malignancies, where it helps to prepare the body for stem cell transplantation. At the molecular level, Fludarabine works by interfering with DNA synthesis, thereby inhibiting the growth of cancer cells. It is classified pharmacologically as an antimetabolite.

Investigated diseases

Hematological Malignancy – Hematological malignancies are cancers that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These diseases can affect the production and function of blood cells, leading to symptoms like fatigue, fever, and frequent infections. They often involve the uncontrolled growth of abnormal blood cells, which can interfere with the normal production of blood cells. Over time, these abnormal cells can accumulate in the blood, bone marrow, or lymph nodes, causing various health issues. The progression of these malignancies can vary widely, with some types growing slowly and others rapidly. Common types include leukemia, lymphoma, and myeloma, each with distinct characteristics and progression patterns.