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临床试验/NCT05780554
NCT05780554Enrolling By Invitation不适用

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

Centro de Hematología y Medicina Interna1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年3月10日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Cyclophosphamide (Drug)

Cyclophosphamide 25 mg/kg

Experimental

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

发起方
Centro de Hematología y Medicina Interna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo J. RUIZ-ARGÜELLES

General director

Centro de Hematología y Medicina Interna

研究点 (1)

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