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Reduced post-transplant cyclophosphamide dose in patients undergoing haploidentical hematopoietic stem cell transplantation for hematological malignancies: a phase III randomized study
EU CTIS ID: 2024-519986-23-00
What this study is testing
The primary objective is to evaluate the efficacy of reducing the total dose of PTCy to 70 mg/kg on GREFS compared to the standard dose of 100 mg/kg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.
- 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
- Age ≥ 18 years
- Confirmed hematological malignancy with an indication for allogeneic HSCT
- Presence of a haploidentical donor willing to donate PBSC
- Patient planned to receive a thiotepa-based conditioning regimen
- Provision of written informed consent
- Affiliation to a social security system (excluding “Aide Médicale d’État”)
You likely can't join if
- Karnofsky performance status < 70%
- Concurrent participation in another investigational therapeutic study
- Inability to comply with study procedures
- Life expectancy < 1 month, as determined by the attending physician
- Acute or chronic heart failure, defined as left ventricular ejection fraction < 40%
- Pulmonary dysfunction with diffusion capacity < 50% of predicted values
See the full eligibility criteria
- Age ≥ 18 years
- Confirmed hematological malignancy with an indication for allogeneic HSCT
- Presence of a haploidentical donor willing to donate PBSC
- Patient planned to receive a thiotepa-based conditioning regimen
- Provision of written informed consent
- Affiliation to a social security system (excluding “Aide Médicale d’État”)
- Karnofsky performance status < 70%
- Concurrent participation in another investigational therapeutic study
- Inability to comply with study procedures
- Life expectancy < 1 month, as determined by the attending physician
- Acute or chronic heart failure, defined as left ventricular ejection fraction < 40%
- Pulmonary dysfunction with diffusion capacity < 50% of predicted values
- Renal impairment with estimated glomerular filtration rate (eGFR) < 45 mL/min (calculated using the CKD-EPI formula)
- Positive HIV status
- Pregnancy, breast-feeding, or refusal to use effective contraception
- Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)
- Hypersensitivity to the active substance or any of the excipients
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.