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

  • STATUS
    Recruiting
  • End date
    Aug 23, 2026
  • participants needed
    540
  • sponsor
    DKMS gemeinnützige GmbH
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Updated on 4 October 2022
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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. 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.

Details
Condition Graft Vs Host Disease, Peripheral Blood Stem Cell Transplantation, AML, MDS, MDS/MPN, CMML
Treatment cyclophosphamide, ATG
Clinical Study IdentifierNCT05153226
SponsorDKMS gemeinnützige GmbH
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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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