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

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What is this study about?

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.

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.

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Philipps-Universitaet Marburg Marburg Germany
Saarland University Hospital Homburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Ubjfjpqyndxdnilhzopxw Eohxh Aji Essen Germany
Mhbemydllyowsjkozdbaecvahf Hunesckoeumvefni Halle (Saale) Germany
Uxwkazagcwmphjnwdouem Arasnzbc Augsburg Germany
Uaoundsocf Hhwohbtn Cnxgklr Cologne Germany
Upjnooeayxdbtjdeilyaw Dstoodfhfla Amz Duesseldorf Germany
Ukyunnzybemdzedxkrsvm Mtllymwd Adn Munster Germany
Ggkfga Ulflykovqp Fscpfkgok Frankfurt Germany
Unlvvdlvnhteipkeyafir Wqqlriers Apd Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.02.2022

Trial locations

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.

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.

Trial ID:
2023-510441-24-00
Protocol code:
DKMS-21-01
NCT ID:
NCT05153226
Trial Phase:
Therapeutic confirmatory (Phase III)

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