NCT05902416Recruiting
Clinical Registration Study of Haplo-HSCT for Elderly Patients With Acute Leukemia/ Myelodysplastic Syndrome
Clinical Registration Study of Haploidentical Stem Cell Transplantation for Elderly Patients With Acute Leukemia or Myelodysplastic Syndrome
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 5 Jun 2023
- Start date
- 1 Jun 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT05902416
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Jun 2023 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are not eligible for hematopoietic stem cell transplantation;
Other illness
- Patients with the severe infections;
Age
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.