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Study on Graft-Versus-Host Disease Prevention Using Cyclophosphamide and Methotrexate in Adults with Blood Cancer Undergoing Matched-Donor Transplant

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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 studying treatments for certain types of blood cancers, specifically *myeloid* and *lymphoid* hematological malignancies. These are cancers that affect the blood, bone marrow, and lymph nodes. The study involves patients who are eligible for a type of treatment called *allogeneic hematopoietic stem cell transplantation*, which uses stem cells from a donor to help the patient's body produce healthy blood cells. The trial aims to test two different conditioning regimens, which are treatments given before the stem cell transplant to prepare the body. These regimens include a combination of medications: *busulfan*, *cyclophosphamide*, *clofarabine*, *fludarabine*, *methotrexate*, *thiotepa*, and *anti-human T-lymphocyte immunoglobulin from rabbits*. The purpose of the study is to estimate the occurrence of a condition called *graft-versus-host disease* (GVHD), which can happen after a stem cell transplant when the donor's cells attack the patient's body.

Participants in the study will receive one of the two conditioning regimens, followed by the stem cell transplant. The medications will be administered through an intravenous route, meaning they will be given directly into a vein. The study will monitor the patients for several outcomes, including the incidence of severe GVHD that does not respond to standard treatments, as well as other factors like overall survival, disease-free survival, and the occurrence of infections. The trial will also assess how well the donor's cells are accepted by the patient's body and how the immune system recovers over time.

This study is designed to help improve the understanding of how different conditioning regimens affect the success of stem cell transplants and the health of patients with blood cancers. By comparing the two regimens, researchers hope to find the most effective way to reduce the risk of complications like GVHD and improve the overall outcomes for patients undergoing this type of treatment. The trial is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, health status, and availability of a suitable donor.

    Consent is required to participate in the study, ensuring understanding of the procedures and potential risks.

  2. Step 2

    Preparation for transplantation

    A conditioning regimen is administered to prepare for the transplantation. This involves receiving medications intravenously to suppress the immune system and make space for new stem cells.

    Medications include busulfan, cyclophosphamide, clofarabine, anti-human t-lymphocyte immunoglobulin from rabbits, fludarabine, methotrexate, and thiotepa.

  3. Step 3

    Transplantation

    The transplantation involves receiving healthy stem cells from a matched donor. This process is similar to a blood transfusion and is done intravenously.

  4. Step 4

    Post-transplant care

    After transplantation, medications such as cyclophosphamide and methotrexate are given to prevent graft-versus-host disease (GVHD), a condition where the donor cells attack the recipient's body.

    Regular monitoring is conducted to assess the uptake of the graft and the patient's recovery.

  5. Step 5

    Follow-up and monitoring

    Follow-up includes regular check-ups to monitor for any signs of GVHD, infections, or other complications.

    The study aims to evaluate the incidence of corticoresistant acute GVHD and other outcomes such as overall survival and disease-free survival over a period of time.

Who can join the trial?

11 criteria

  • Age between 18 and 70 years old.
  • Negative tests for Hepatitis B, Hepatitis C, and HIV.
  • Must have social security affiliation.
  • Diagnosed with a blood-related cancer, known as a hematologic malignancy.
  • Need for a type of treatment called allogeneic hematopoietic stem cell transplantation with a less intense preparation process.
  • Use of peripheral stem cell graft, which means stem cells are collected from the bloodstream.
  • Must have a donor who is a perfect match (10/10) for HLA, which is a protein important for the immune system, either from family or non-family.
  • Agreement to participate in the study, known as protocol consent.
  • Have an ECOG score of 2 or less, which is a scale to measure daily living abilities, where lower scores mean better function.
  • Women who can have children must have a negative pregnancy test and use highly effective birth control during treatment and for 12 months after stopping certain medications (CY and MTX).
  • Men who can have children must use effective birth control during treatment and for 6 months after stopping certain medications (CY and MTX).
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Investigated drugs

  • Cyclophosphamide

    is a medication used in this trial to help prevent graft-versus-host disease (GVHD) after a transplant. It works by suppressing the immune system, which can help reduce the risk of the body rejecting the transplanted cells.

  • Methotrexate

    is another medication used in the trial for the prevention of GVHD. It also helps to suppress the immune system, working alongside cyclophosphamide to protect the transplanted cells from being attacked by the patient's immune system.

What is already known about the treatment

  • Cyclophosphamide

    Cyclophosphamide is administered intravenously and is used in the context of hematological malignancies, particularly in patients undergoing allogeneic hematopoietic stem cell transplantation. It is currently well-established in medical literature as a prophylactic treatment to prevent graft-versus-host disease (GVHD). The main therapeutic indication is to reduce the incidence of acute GVHD in patients receiving a matched-donor transplant. Cyclophosphamide works by interfering with the DNA replication process in rapidly dividing cells, thereby suppressing the immune response. It is classified as an alkylating agent in pharmacology.

  • Methotrexate

    Methotrexate is typically administered intravenously and is used in combination with other medications to prevent graft-versus-host disease in patients undergoing stem cell transplantation. It is widely recognized in medical literature for its role in reducing the risk of GVHD. The primary therapeutic indication is to serve as a prophylactic agent against GVHD in patients receiving a matched-donor transplant. Methotrexate acts by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis, thus reducing the proliferation of immune cells. It is classified as an antimetabolite in pharmacology.

Investigated diseases

Acute Graft-versus-Host Disease (GVHD) – This condition occurs when donor immune cells attack the recipient's body after a stem cell or bone marrow transplant. It typically affects the skin, liver, and gastrointestinal tract. Symptoms can include skin rashes, jaundice, and diarrhea. The severity of the disease is graded from 1 to 4, with higher grades indicating more severe symptoms. Acute GVHD usually develops within the first 100 days post-transplant. The progression can vary, with some cases resolving spontaneously while others may become chronic or require medical intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509042-35-01Protocol codeRC23_0286Estimated enrolment82 patientsSponsorCentre Hospitalier Universitaire De Nantes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).