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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

NCT06681922

Graft Vs Host Disease

RECRUITING PHASE1/PHASE2

Efficacy of Low-dose PT-Cy for Prevention of GVHD in Ambulatory Allogeneic HSCT

NCT07319000

Graft Versus Host Disease

COMPLETED PHASE2

Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination with Post-engraftment Anti-thymoglobin As Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

NCT06705062

Allogeneic Hematopoietic Cell Transplant Graft Versus Host Disease

ACTIVE_NOT_RECRUITING PHASE3

Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis

NCT05158608

Graft Versus Host Disease Hematologic Malignancy Cyclophosphamide Adverse Reaction

UNKNOWN PHASE3

Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

NCT06000982

GVHD

NOT_YET_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 malignancy, or PTCy-associated adverse event, whichever comes first from transplantation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

GVHD - Graft-Versus-Host Disease HSCT Haploidentical Stem Cell Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reduced dose

cyclophosphamide administered at 35mg/kg/day on days +3 and +4

Group Type EXPERIMENTAL

Cyclophosphamide 35mg/kg/day

Intervention Type DRUG

Cyclophosphamide will be administered intravenously (IV) post-HSCT at the experimental dose (70 mg/kg, divided into two doses of 35 mg/kg/day on days +3 and +4).

Standard dose

cyclophosphamide administered at 50mg/kg/day on days +3 and +4

Group Type ACTIVE_COMPARATOR

Cyclophosphamide 50mg/kg/day

Intervention Type DRUG

Cyclophosphamide will be administered intravenously (IV) post-HSCT at the standard dose (100 mg/kg, divided into two doses of 50 mg/kg/day on days +3 and +4).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclophosphamide 35mg/kg/day

Cyclophosphamide will be administered intravenously (IV) post-HSCT at the experimental dose (70 mg/kg, divided into two doses of 35 mg/kg/day on days +3 and +4).

Intervention Type DRUG

Cyclophosphamide 50mg/kg/day

Cyclophosphamide will be administered intravenously (IV) post-HSCT at the standard dose (100 mg/kg, divided into two doses of 50 mg/kg/day on days +3 and +4).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No