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

NCT07319000 | Completed Phase 2 DMC

• 1 other identifier: HE22-0037
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease

Keywords

Transplants; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Low-dose post-transplant cyclophosphamide

EXPERIMENTAL

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.

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

low-dose post-transplant cyclophosphamide

Low-dose post-transplant cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario de Monterrey

Monterrey, 64460, Mexico

Location

Related Publications (1)

• Sugita J, Kamimura T, Ishikawa T, Ota S, Eto T, Kuroha T, Miyazaki Y, Kumagai H, Matsuo K, Akashi K, Taniguchi S, Harada M, Teshima T. Reduced dose of posttransplant cyclophosphamide in HLA-haploidentical peripheral blood stem cell transplantation. Bone Marrow Transplant. 2021 Mar;56(3):596-604. doi: 10.1038/s41409-020-01065-0. Epub 2020 Sep 24.

  PMID: 32973350 RESULT

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hematology Service

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

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)