NCT05902416 Clinical Registration Study of Haplo-HSCT for Elderly Patients With Acute Leukemia/ Myelodysplastic Syndrome
| NCT ID | NCT05902416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Acute Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-06-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05902416 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 70 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05902416 currently recruiting?
Yes, NCT05902416 is actively recruiting participants. Contact the research team at sunyuqian83@hotmail.com for enrollment information.
Where is the NCT05902416 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05902416 clinical trial?
NCT05902416 is sponsored by Peking University People's Hospital. The trial plans to enroll 120 participants.
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