Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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

Treatment groups

180 Participants
are divided into 2 treatment groups