An interventional study of Cyclophosphamide and Cyclophosphamide in Graft Vs Host Disease, sponsored by Centro de Hematología y Medicina Interna. Status unknown at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Centro de Hematología y Medicina Interna · Not applicable, Interventional, and Prevention
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.
815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's planned enrollment of 42 is above the median of 35 across 643 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Centro de Hematología y Medicina Interna is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Drug: Cyclophosphamide
Drug: Cyclophosphamide
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4
Acute GVHD rate
Incidence of acute GVHD after HSCT
Time frame: 6 months
Chronic GVHD rate
Incidence of chronic GVHD after HSCT
Time frame: 18 months
Relapse free survival
Incidence of relapse of the disease after HSCT
Time frame: 12 months
Overall survival
Patients survival after therapy
Time frame: 12 months
Started Mar 2023 (actual). Primary completion is estimated for Mar 2025, 24 months after the start.
Of 33 interventional studies with no phase under Graft vs Host Disease, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclophosphamide
Centro de Hematología y Medicina Interna