BridgeMD
GRAPPA
EU CTIS ID: 2023-510441-24-00
What this study is testing
One of the key elements to improve allogeneic HCT is the administration of optimized conditioning treatment including immunosuppressive drugs to facilitate engraftment, prevent GVHD and induce tolerance of donor immune cells. Specifically, the goal of this trial is to investigate the impact of PTCY versus ATG Grafalon ® as part of a conditioning treatment for alloHCT on overall survival (OS) and on graft-versus host disease-free and relapse-free survival (GRFS). Information on the investigational drugs provided by these two endpoints will enable the scientific community a comprehensive assessment of the two approaches for alloHCT.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written Informed Consent and able to understand the nature of the trial and the trial related procedures and to comply with them (see Section 24.3). − Age ≥ 18 years. − One of the following eligible diagnoses: - AML in CR1 with intermediate or adverse risk genetic abnormalities (according to the ELN 2022 guidelines1), or undefined risk. - AML of any ELN risk category after hematological or molecular relapse0F a, or with primary refractory disease. - AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN 2022 guidelines1) are present. - Therapy-related myeloid neoplasia (t-MN), except if favourable genetic abnormalities (according to ELN 2022 guidelines1) are present. - MDS with intermediate risk, high risk or very high risk disease according to the IPSS-R Score or MDS with moderate high, high, or very high risk disease according to the IPSS-M Score2 regardless of treatment status. - MDS/MPN and CMML-1/CMML-2 according to WHO 20223 regardless of treatment status. − The left ventricular ejection fraction (LVEF) was ≥40% at last assessment. − Planned transplantation with Peripheral Blood Stem Cells (PBSC). − Transplantation 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 (see Section 17.7). 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.
You likely can't join if
- − 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 (see Section 17.7). − Simultaneous participation in another interventional clinical trial with an investigational medicinal product.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.