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

Efficacy of Low-dose Post-transplant Cyclophosphamide for Prevention of Graft-versus-host Disease in Ambulatory Allogeneic Hematopoietic Stem Cell Transplantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07319000

Enrollment

Registered

2026-01-06

Start date

2023-01-01

Completion date

2023-12-31

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Keywords

Transplants, Cyclophosphamide

Brief summary

Low-dose post-transplant cyclophosphamide have demonstrated therapeutic efficacy in allogeneic stem cell transplants which is comparable with the standard dose and also facilitates early hematological recovery.

Detailed description

Graft-versus-host disease (GVHD) is the most important complication that occurs in hematopoietic stem cell transplantation (HSCT). GVHD prophylaxis based on the use of post-transplant cyclophosphamide (PT-Cy) has proven to be a practical, easily and accessible agent that allows both identical and haploidentical transplants to be performed with lower incidences of this disease. Low-dose cyclophosphamide have already demonstrated therapeutic efficacy in these types of transplants which is comparable with the standard dose and also facilitates early hematological recovery that can in turn reduce risks of infection, hospital stay and total costs for the patient. The investigators will conduct a phase 2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of of low-dose PT-Cy which is accessible to a population with limited resources while maintaining acceptable efficacy and safety to prevent GVHD.

Interventions

DRUGCyclophosphamide

low-dose post-transplant cyclophosphamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A consecutive sample of 35 patients undergoing allogeneic transplantation will be included and will be administered low-dose post-transplant cyclophosphamide.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>18 years. * Both genders. * Diagnosis of any blood disease in need of an allogeneic bone marrow transplant (aplastic anemia, acute myeloid leukemia, chronic granulocytic leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, Hodgkin lymphoma, and Non-Hodgkin lymphoma). * Patients who have compatible related donors to perform an identical or haploidentical allogeneic transplant. * Patients with functional status 0 to 2 using the ECOG scale.

Exclusion criteria

* Poor functional status (ECOG\>2). * Organic dysfunction (Marshall score ≥2). * Pregnancy * Heart failure (NYHA III or IV). * Renal failure (GFR \<30 ml/min/1.72m2). * History of ventricular arrhythmias or uncontrolled arrhythmias. * Acute myocardial infarction, unstable angina, or stable angina in the last six months. * Uncontrolled active infection. * Liver disease (Child-Pugh C). * Patients not approved by the local transplant committee for any other reason.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of Low-dose PT-Cy	6 months	Low-dose PT-Cy (30 and 40 mg/kg/day/2 days) is effective in achieving an incidence of grade III/IV (Glucksberg grade) acute GVHD and moderate to severe chronic GVHD equal to or below historical controls of 20 and 30%, respectively.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026