Status:
NOT_YET_RECRUITING
Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
GVHD - Graft-Versus-Host Disease
HSCT
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 patie...
Detailed Description
The primary endpoint is the assessment of the GREFS at 2 years after HSCT, a composite endpoint defined as the probability of survival without severe GVHD, relapse/progression of the hematological mal...
Eligibility Criteria
Inclusion
- 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")
Exclusion
- 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
- Renal impairment with estimated glomerular filtration rate (eGFR) \< 45 mL/min (calculated using the CKD-EPI formula)
- Decompensated hemolytic anemia
- Fanconi anemia and other DNA breakage repair disorders
- Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy
- Obstruction of urinary outflow
- Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
- Combination with products containing Hypericum perforatum
- Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren
- Active non-controlled infectious disease
- Positive HIV status
- Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose
- 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
- Concurrent participation in another investigational therapeutic study
- Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:
- Significant language barrier in the absence of adequate translation support
- Social or geographic situation preventing follow-up and adherence to visit schedule
- Ongoing substance abuse likely to interfere with protocol compliance
- Documented cognitive or functional impairment not otherwise covered under legal protection
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07193420
Start Date
September 1 2025
End Date
September 1 2029
Last Update
September 25 2025
Active Locations (1)
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1
Saint Antoine Hospital - Hematology Department
Paris, France, 75012