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Graft Vs Host DiseasePhase 3GRAPPANCT05153226

GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG

A Phase 3 study testing Cyclophosphamide and ATG in people with Graft Vs Host Disease and Peripheral Blood Stem Cell Transplantation, run by DKMS gemeinnützige GmbH at 23 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cyclophosphamide and ATG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
23 sitesGermany
Study dates
2 Mar 2022to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Uniklinik RWTH Aachen

    Aachen, 52074

  • Univeristätsklinikum Augsburg

    Augsburg, 86156

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Universitätsklinikum Köln

    Cologne, 50937

  • St.-Johannes-Hospital Dortmund

    Dortmund, 44137

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Uniklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen (AöR)

    Essen, 45147

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60595

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Philipps Universität Marburg

    Marburg, 35043

  • Universitätsklinikum Münster

    Münster, 48149

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Graft vs Host Disease Prophylaxis in Unrelated Donor Transplantation: a Randomized Clinical Trial Comparing PTCY vs ATG (GRAPPA)

Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. GVHD prophylaxis for matched unrelated donor hematopoietic cell transplantation (alloHCT) in Europe is mainly conducted with ATG. Still, the burden of acute and chronic GVHD and especially of relapse remains high with both approaches for GVHD prevention.

PTCY has not been tested against the current standard ATG for GvHD prophylaxis in large randomized trials. The goal of this trial is to compare the outcomes of PTCY and ATG for patients receiving unrelated donor PBSCT. PTCY-based prophylaxis promises to have beneficial net effects on immune reconstitution, GVHD and disease control, and thus might impact on patient survival.

Being tested
Cyclophosphamide, ATG
Keywords
Graft vs Host Disease, Peripheral Blood Stem Cell Transplantation, Cyclophsophamide, Anti-thymocyte globulin (rabbit)
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Also called all brands

    50 mg/kg (AIBW) i.v. d+3, d+4 post transplant

  • ATGBiological

    Also called ATG Grafalon

    10 mg/kg i.v. d-3, d-2, d-1 pre-transplant

Study groups in NCT05153226
Study groupRoleWhat they receive
CyclophosphamideExperimentalCyclophosphamide 50 mg/kg (AIBW) i.v. d+3, d+4 post transplant
Receives: Drug: Cyclophosphamide
ATGActive comparatorATG Grafalon 10 mg/kg i.v. d-3, d-2, d-1 pre-transplant
Receives: Biological: ATG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: from randomization

  2. GVHD- and relapse-free survival (GRFS)

    Measured: from HCT

Secondary outcomes (6)

  1. Overall survival

    Measured: from HCT

  2. Relapse- and immunosuppression-free survival (RIFS)

    Measured: from HCT

  3. Event-free survival

    Measured: 1 year

  4. Cumulative incidence of relapse

    Measured: 1 year

  5. Cumulative incidence of non-relapse mortality

    Measured: 1 year

  6. Cumulative incidences of acute and chronic GVHD

    Measured: 180 days and 2 years after HCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start2 Mar 2022
  3. Primary completion31 Mar 2026
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153226
Sponsor's protocol ID
DKMS-21-01
Other IDs
2021-000853-17
Acronym
GRAPPA
Status last verified
Aug 2026
First submitted
26 Nov 2021
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide and ATG in people with Graft Vs Host Disease and Peripheral Blood Stem Cell Transplantation, run by DKMS gemeinnützige GmbH at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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