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

Phase 2CompletedNCT07319000

Hospital Universitario Dr. Jose E. Gonzalez35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft Versus Host Disease

Interventions

CyclophosphamideDRUG

low-dose post-transplant cyclophosphamide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario de Monterrey

Monterrey, Mexico

Outcomes

Primary Outcomes

Efficacy of Low-dose PT-Cy

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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