Clinical trial · Interventional
Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies
Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study
NCT07193420CI-TRIAL-00111158REDUCynot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GVHD - Graft-Versus-Host Disease | — | UNRESOLVED | — |
| Haploidentical Stem Cell Transplantation | — | UNRESOLVED | — |
| HSCT | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 35mg/kg/day | Drug | — | UNRESOLVED |
| Cyclophosphamide 50mg/kg/day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced dose
- description
- cyclophosphamide administered at 35mg/kg/day (Adjusted body weight) on days +3 and +4
- interventionNames
- Drug: Cyclophosphamide 35mg/kg/day
- type
- ACTIVE_COMPARATOR
- label
- Standard dose
- description
- cyclophosphamide administered at 50mg/kg/day (Adjusted Body Weight) on days +3 and +4
- interventionNames
- Drug: Cyclophosphamide 50mg/kg/day
Primary outcomes (1)
- measure
- GVHD-free, relapse-free, event-free survival (GREFS)
- timeFrame
- Day 0 to first occurrence of acute grade III-IV GVHD, severe chronic GVHD, relapse, death, grade 3-4 cardiac event, or grade 3-4 BK virus-associated HC (up to 24 months post-transplant); platelet recovery (>50 × 10^9/L) assessed until Day +60
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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") Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.