Evaluating the Beijing protocol for patients with highly mismatched stem cell transplants
The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
This study is testing a new approach for patients with blood cancers who need stem cell transplants from mismatched donors to see if it can improve their treatment results and safety.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | N/A to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05921318 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of the Beijing protocol in patients with hematologic malignancies who are receiving allogeneic hematopoietic stem cell transplants (allo-HSCT) from donors with more than 5/10 HLA mismatches. The study addresses the challenges posed by HLA incompatibility, which can increase the risk of complications such as graft-versus-host disease (GvHD) and non-relapse mortality. By exploring new strategies to utilize highly mismatched donors, the study seeks to improve transplant outcomes for patients who lack suitable matched donors. Participants will be monitored for safety and efficacy outcomes throughout the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with hematologic malignancies who require allo-HSCT but do not have access to HLA-matched or haploidentical donors.
Not a fit: Patients with severe infections, pregnant or lactating women, or those who are not eligible for stem cell transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with hematologic malignancies who currently have limited access to suitable stem cell donors.
How similar studies have performed: While the approach of using highly mismatched donors is challenging, there have been some studies exploring similar strategies, but the efficacy of the Beijing protocol specifically remains to be fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * hematologic malignancy patients * patients eligible for the transplantation of allogeneic hematopoietic stem cells; * patients unavailable with HLA matched donor or related haploidentical donor * voluntary participation in this study and signing the informed consent form. Exclusion Criteria: * Patients with the severe infections; * Pregnant or lactating women * 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 this trial is running
Beijing, Beijing Municipality
- Deparment of Hematology, Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiaojun Huang, Prof. — Peking University People's Hospital
- Study coordinator: Yu Wang, Prof.
- Email: ywyw3172@sina.com
- Phone: 13552647384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.