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Can a new drug regimen beat the standard for stem cell transplant complications?

NCT ID NCT05153226

Disease control Sponsor: DKMS gemeinnützige GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a drug called cyclophosphamide (PTCY) can prevent graft-versus-host disease (GVHD) better than the current standard, ATG, in patients receiving stem cell transplants from unrelated donors. GVHD is a serious complication where donor immune cells attack the patient's body. The study includes adults with blood cancers like AML or MDS. Half receive PTCY after transplant, the other half receive ATG before transplant. Researchers will compare survival, GVHD rates, and relapse rates to see which approach offers better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two drugs are compared: cyclophosphamide (PTCY), given after transplant, and anti-thymocyte globulin (ATG), given before transplant, to prevent graft-versus-host disease.
What this could lead to
If PTCY works better than ATG, it could reduce graft-versus-host disease and relapse, improving survival for patients receiving unrelated donor stem cell transplants.
What could go wrong
This is a large trial, but results may not show a clear winner. Both drugs have risks, including infection, organ damage, and the chance that the transplant fails or the disease returns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

640 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed written Informed Consent and able to understand the nature of the trial and the trial related procedures and to comply with them. * Age ≥ 18 years. * One of the following eligible diagnoses: AML in CR1 with intermediate or adverse risk genetic abnormalities (according to the ELN 2017 guidelines), or undefined risk. AML of any ELN risk category after hematological or molecular relapse, or with primary refractory disease. AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present. Therapy-related myeloid neoplasia (t-MN), except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present. MDS with intermediate risk, high risk or very high risk disease (according to the IPSS-R Score) regardless of treatment status. MDS/MPN and CMML-1/CMML-2 regardless of treatment status. * The left ventricular ejection fraction (LVEF) was assessed ≥40% at last echocardiography. * Transplantation with Peripheral Blood Stem Cells (PBSC) scheduled to be performed 4 to 14 days after date of randomization. * The scheduled donor is unrelated to the patient, and matched or partially matched (with not more than one allele or antigen mismatch) at HLA-A, -B, -C, or -DRB1. * Absence of pregnancy confirmed by highly sensitive pregnancy test for WOCBP. Test must not date back more than 3 days prior to randomization, or more than 3 days prior to start of conditioning, if it started before randomization. Exclusion Criteria: * Anamnestic intravenous or subcutaneous exposure to rabbit immunoglobin-preparations (e.g. Grafalon or Thymoglobulin) * Known hypersensitivity to ATG-Grafalon or its excipients. * Known hypersensitivity to cyclophosphamide, its metabolites or excipients. * Prior allogeneic hematopoietic transplantation. * Patients who receive supplementary continuous oxygen at the time of randomization. * Symptomatic heart failure (NYHA ≥2) at the time of randomization. * Uncontrolled viral, bacterial or fungal infection with progression or no clinical improvement at the time of randomization. * Symptomatic cystitis or known obstruction of urine flow at the time of randomization. * Breast-feeding women. * WOCBP and fertile male patients unable or unwilling to follow highly effective contraception methods from enrollment to minimum six months after the last dose of the IMP. * Simultaneous participation in another interventional clinical trial with an investigational medicinal product.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia chronic myelomonocytic leukemia graft versus host disease myelodysplastic syndrome myelodysplastic/myeloproliferative neoplasm therapy-related myeloid neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML CMML Graft-VS-host disease MDS MDS/MPN Peripheral blood stem cell transplantation

Contacts and locations

Locations

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113, Germany

  • Klinikum Nürnberg Nord

    Nuremberg, 90419, Germany

  • Philipps Universität Marburg

    Marburg, 35043, Germany

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376, Germany

  • St.-Johannes-Hospital Dortmund

    Dortmund, 44137, Germany

  • Uniklinik RWTH Aachen

    Aachen, 52074, Germany

  • Uniklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Univeristätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Essen (AöR)

    Essen, 45147, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60595, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitätsklinikum Jena

    Jena, 07747, Germany

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsklinikum des Saarlandes

    Homburg, 66421, Germany

  • Universitätsmedizin Mainz

    Mainz, 55131, Germany

  • Universitätsmedizin Mannheim

    Mannheim, 68167, Germany

  • Universitätsmedizin Rostock

    Rostock, 18057, Germany

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