Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg

Not Applicable

• Conditions: Graft Vs Host Disease
• Interventions: Drug: Cyclophosphamide

• Registration Number: NCT05780554
• Lead Sponsor: Centro de Hematología y Medicina Interna

Brief Summary

Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood.

In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-10
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-22
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases).
• Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver.

Exclusion Criteria

• Patients who refuse to sign the consent form.
• Latent infection.
• Hepatic, cardiac or bronchopulmonary symptomatic diseases
• Abnormalities on previous clinical hematological appointments, considered as contraindication.
• Positive serology for HIV, VHB, VHC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide 25 mg/kg	Cyclophosphamide	-
Cyclophosphamide 50 mg/kg	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Acute GVHD rate	6 months	Incidence of acute GVHD after HSCT
Chronic GVHD rate	18 months	Incidence of chronic GVHD after HSCT
Relapse free survival	12 months	Incidence of relapse of the disease after HSCT
Overall survival	12 months	Patients survival after therapy

Trial Locations

Locations (1)

Centro de Hematología y Medicina Interna; 🇲🇽 Puebla, Mexico