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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-dose post-transplant cyclophosphamide

Low dose post-transplant cyclophosphamide therapy will be administered as follows:

Allogeneic stem cell transplant:

Cyclophosphamide 30/mg/kg/day for 2 continuous days.

Haploidentical stem cell transplant:

Cyclophosphamide 40/mg/kg/day for 2 continuous days.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

low-dose post-transplant cyclophosphamide

Interventions

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Cyclophosphamide

low-dose post-transplant cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No