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Comparison of Post-Transplant Cyclophosphamide versus Anti-T Lymphocyte Immunoglobulin for Prevention of Graft versus Host Disease in Patients Receiving Unrelated Donor Transplantation

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on preventing Graft Versus Host Disease, a condition that can occur after stem cell transplantation from an unrelated donor. The study will involve patients with various blood disorders including Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Chronic Myelomonocytic Leukemia. The purpose is to compare two different approaches to prevent complications after transplantation.

The study will use several medications including cyclophosphamide, mycophenolate mofetil, and tacrolimus. One group of patients will receive Grafalon, which contains antibodies that affect the immune system, while another group will receive a different combination of medications. These medications will be given through infusion into a vein or taken by mouth.

The treatment will be given around the time of the stem cell transplantation. Patients will receive their assigned medications according to a specific schedule, with some treatments lasting a few days and others continuing for several months. The medications are used to help the body accept the transplanted cells and prevent rejection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
You will receive peripheral blood stem cell transplantation from an unrelated donor who is matched or partially matched to your tissue type.
The transplantation will be scheduled between 4 to 14 days after your enrollment in the study.
Step 2
Treatment paths
Based on random assignment, you will receive one of two treatment options:
Option 1: Post-transplant cyclophosphamide (PTCY) administered through infusion
Option 2: Anti-T lymphocyte immunoglobulin (ATG Grafalon) administered through infusion
Step 3
Additional medications
You will receive additional medications to help prevent complications:
Mycophenolic acid - taken by mouth
Tacrolimus - taken by mouth
These medications help prevent rejection and support your immune system after transplantation
Step 4
Follow-up period
Your progress will be monitored to assess:
Overall survival and recovery
Freedom from complications related to transplant
Response to treatment
The study will continue until March 31, 2027

Who can join the trial?

12 criteria

Must be at least 18 years old
Must have one of these conditions:
- Acute Myeloid Leukemia (AML) in first complete remission with intermediate or high-risk genetic features
- AML that has returned after previous treatment or did not respond to initial treatment
- AML that developed from other blood disorders
- Myelodysplastic Syndrome (MDS) with intermediate to very high-risk features
- Mixed MDS/MPN conditions or Chronic Myelomonocytic Leukemia (CMML)
- Must have heart function test showing left ventricular ejection fraction (heart pumping ability) of 40% or higher
- Must be scheduled to receive Peripheral Blood Stem Cells (blood-forming cells collected from a donor's bloodstream)
- Transplant must be planned between 4 to 14 days after being assigned to a treatment group
- Must have an unrelated donor whose tissue type matches the patient's tissue type (with no more than one mismatch)
- Must be able to understand and sign informed consent documents
- Women who can become pregnant must have a negative pregnancy test within 3 days before starting treatment

Who cannot join the trial?

16 criteria

Age below 18 years or above 65 years
Pregnancy or breastfeeding
Previous stem cell transplantation (a procedure where healthy blood-forming cells are used to replace damaged ones)
Active uncontrolled infections
Severe heart conditions or significant heart disease
Severe lung disease
Severe kidney dysfunction
Severe liver dysfunction
Active, uncontrolled psychiatric disorders
Known allergy or hypersensitivity to study medications
Participation in another clinical trial within the last 30 days
HIV positive status
Active hepatitis B or C infection
Inability to provide informed consent
Cancer that has spread to the central nervous system (brain and spinal cord)
Poor performance status that limits daily activities significantly

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
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Mainz, Germany
Goethe University Frankfurt
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Frankfurt, Germany
Klinikum Nuernberg
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Nürnberg, Germany

Trial locations

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Investigated drugs

Post-transplant cyclophosphamide (PTCY)
This is a medication given after bone marrow transplantation to prevent graft-versus-host disease (GVHD). It works by suppressing the immune system to help prevent the donated cells from attacking the recipient's body. It is commonly used in transplants from unrelated donors.
Anti-thymocyte globulin (ATG Grafalon)
This is an antibody medication that suppresses the immune system and is used to prevent rejection in organ and stem cell transplants. It specifically targets certain immune cells (T-cells) to reduce the risk of graft-versus-host disease. It is administered as part of the conditioning treatment before the transplant procedure.

What is already known about the treatment

ATG (Anti-thymocyte globulin)
An immunosuppressive medication administered intravenously as part of conditioning treatment before stem cell transplantation. It works by targeting and reducing T-lymphocytes in the body, helping to prevent graft-versus-host disease (GVHD) in patients receiving stem cell transplants. ATG belongs to the class of polyclonal antibodies and is specifically used in allogeneic hematopoietic cell transplantation for patients with conditions such as AML, MDS, and other blood disorders.
Cyclophosphamide (PTCY)
A chemotherapy medication given intravenously post-transplantation to prevent graft-versus-host disease in patients receiving stem cell transplants. It functions by selectively eliminating activated T-cells that could cause GVHD while preserving resting T-cells and stem cells. This medication belongs to the alkylating agents class and has become an increasingly popular alternative to traditional GVHD prophylaxis in unrelated donor transplantation.

Investigated diseases

Graft Versus Host Disease
A condition that occurs when donated stem cells or bone marrow view the recipient's body as foreign and attack it. The condition typically affects the skin, liver, and digestive system. The immune cells from the donor (graft) attack the recipient's (host) tissues.
Acute Myeloid Leukemia (AML)
A type of blood and bone marrow cancer where the body produces abnormal myeloid cells. These immature cells build up in the bone marrow and interfere with the production of normal blood cells. The disease develops rapidly, affecting the production of red blood cells, white blood cells, and platelets.
Myelodysplastic Syndromes (MDS)
A group of blood disorders where blood cells in the bone marrow do not mature properly. The immature blood cells fail to develop normally and die in the bone marrow or blood. This leads to low blood cell counts and poorly functioning blood cells.
Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN)
A group of blood disorders that have features of both myelodysplastic syndromes and myeloproliferative conditions. These conditions affect blood cell production and maturation, showing both decreased and increased cell production simultaneously.
Chronic Myelomonocytic Leukemia (CMML)
A blood cancer that affects blood-forming cells in the bone marrow. It causes an increase in white blood cells called monocytes, while other blood cells may be either increased or decreased. The condition has characteristics of both myelodysplastic syndrome and myeloproliferative disorder.