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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05780554
Enrollment
42
Registered
2023-03-22
Start date
2023-03-10
Completion date
2025-03-20
Last updated
2023-03-23

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

Conditions

Graft Vs Host Disease

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.

Interventions

DRUGCyclophosphamide

Post transplant cyclophosphamide 25 mg/kg on day +3 and +4

Sponsors

Centro de Hematología y Medicina Interna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute GVHD rate6 monthsIncidence of acute GVHD after HSCT
Chronic GVHD rate18 monthsIncidence of chronic GVHD after HSCT
Relapse free survival12 monthsIncidence of relapse of the disease after HSCT
Overall survival12 monthsPatients survival after therapy

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026