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 study about?

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.

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 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 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 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 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 Study?

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).

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cmkqxe Hlnaitqxxzz Rkpaksvi Dzryhjjbidbmfz	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2024

Trial locations

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.

Investigated diseases:

Graft versus host disease

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 ID:

2023-509042-35-01

Protocol code:

RC23_0286

NCT ID:

NCT06252870

Trial Phase:

Therapeutic exploratory (Phase II)

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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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