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

NCT05902416 | Recruiting

• 1 other identifier: 2022PHB352-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Leukemia; Myelodysplastic Syndromes

Keywords

RIC regimen; Elderly; comorbidity; transplant-related mortality; Haplo-HSCT

Outcome Measures

Primary Outcomes (1)

• 1-year LFS

  defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.

  Participants will be followed for an expected average of 1 years

Secondary Outcomes (2)

• 1-year OS

  Participants will be followed for an expected average of 1 years

• 1-year TRM

  Participants will be followed for an expected average of 1 years

Other Outcomes (2)

• Adverse event

  Participants will be followed for an expected average of 1 years

• Engraftment rate

  Participants will be followed for an expected average of 1 years

Study Arms (1)

RIC regimen,Elderly,Haplo-HSCT,PFS,OS,TRM

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥55 years of age and \<70 years of age, with acute leukemia or MDS (with or without HCT-CI≥3)

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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Sun

CONTACT

01088326666; sunyuqian83@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)