Clinical Registration Study of Haplo-HSCT for Elderly Patients With Acute Leukemia/ Myelodysplastic Syndrome

Recruiting now

Conditions studied: Acute Leukemia, Myelodysplastic Syndromes

In brief

This study is an open, prospective, single-center, single-arm study expanded based on the study of NCT03412409.The primary objective of this study is to evaluate the transplantation efficacy of the RIC conditioning regimen in elderly patients receiving the transplantation of haploidentical hematopoietic stem cells. Elderly patients are defined as ≥55 years of age; High comorbidity is defined as an HCT-CI score ≥3.Primary endpoint is 1-year LFS. Secondary endpoints are 1-year OS and 1-year TRM, Other indicators to be assessed in this study include acute GVHD, chronic GVHD, CMV activation, EBV activation, engraftment.

Key facts

Study ID

NCT05902416

Run by

Peking University People's Hospital

People needed

120

Starts

2023-06-01

Expected to finish

2026-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 55 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥55 years of age and <70 years of age, with acute leukemia or MDS (with or without HCT-CI≥3);
• Patients eligible for the transplantation of allogeneic hematopoietic stem cells;
• Patients unavailable with HLA matched donors but available with haploidentical donors;
• Voluntary participation in this study and signing the informed consent form.

You may not qualify if…

• Patients with the severe infections;
• Pregnant or lactating women or female and male subjects of childbearing age and their spouses who are unable to secure effective contraception during the dosing period and within 90 days after the end of the dosing period.
• Patients who are not eligible for hematopoietic stem cell transplantation;
• Patients who are enrolled in other clinical trials within 1 month;
• Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
• Patients unable to properly understand or refusing to accept the informed consent form.

Where it is running

• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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