Actively Recruiting

Age: 55Years - 70Years
All Genders
NCT05902416

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

Led by Peking University People's Hospital · Updated on 2024-09-19

120

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 55 years or older and younger than 70 years with acute leukemia or myelodysplastic syndrome, with or without a high comorbidity score (HCT-CI 653)
  • Patients eligible for allogeneic hematopoietic stem cell transplantation
  • Patients without HLA matched donors but with available haploidentical donors
  • Patients who voluntarily agree to participate and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Patients with severe infections
  • Pregnant or breastfeeding women, or males and females of childbearing potential and their partners who cannot use effective contraception during treatment and for 90 days after
  • Patients not eligible for hematopoietic stem cell transplantation
  • Patients enrolled in other clinical trials within the past month
  • Patients unlikely to complete the study or considered unsuitable by the investigator
  • Patients unable to understand or refusing to sign the informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

S

Sun

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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