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

Study Overview
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Brief Summary
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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.

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

Conditions
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Graft Vs Host Disease

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclophosphamide 50 mg/kg<br> | Drug: Cyclophosphamide<br>* Post transplant cyclophosphamide 50 mg/kg on day +3 and +4<br>|
| Experimental: Cyclophosphamide 25 mg/kg<br> | Drug: Cyclophosphamide<br>* Post transplant cyclophosphamide 25 mg/kg on day +3 and +4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute GVHD rate | Incidence of acute GVHD after HSCT | 6 months | 
| Chronic GVHD rate | Incidence of chronic GVHD after HSCT | 18 months | 
| Relapse free survival | Incidence of relapse of the disease after HSCT | 12 months | 
| Overall survival | Patients survival after therapy | 12 months |