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

Graft Vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05780554
• Other study ID #: CHMI-020323-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2023
• Source: Centro de Hematología y Medicina Interna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: March 20, 2025
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Vs Host Disease

Intervention

Drug:
• Cyclophosphamide
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
• Cyclophosphamide
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4

Locations

Country	Name	City	State
Mexico	Centro de Hematología y Medicina Interna	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Hematología y Medicina Interna

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute GVHD rate	Incidence of acute GVHD after HSCT	6 months
Primary	Chronic GVHD rate	Incidence of chronic GVHD after HSCT	18 months
Primary	Relapse free survival	Incidence of relapse of the disease after HSCT	12 months
Primary	Overall survival	Patients survival after therapy	12 months