Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Acute GVHD rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cyclophosphamide 50 mg/kg
干预措施: Cyclophosphamide (Drug)
Cyclophosphamide 25 mg/kg
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Acute GVHD rate
时间窗: 6 months
Incidence of acute GVHD after HSCT
Chronic GVHD rate
时间窗: 18 months
Incidence of chronic GVHD after HSCT
Relapse free survival
时间窗: 12 months
Incidence of relapse of the disease after HSCT
Overall survival
时间窗: 12 months
Patients survival after therapy
次要结局
未报告次要终点
研究者
Guillermo J. RUIZ-ARGÜELLES
General director
Centro de Hematología y Medicina Interna
