About this trial
Phase III comparative, open-label, randomized (1:1) trial designed 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Karnofsky performance status < 70%
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
Trial design
Treatments tested in this trial
- Cyclophosphamide 35mg/kg/day
- Cyclophosphamide 50mg/kg/day