Comparing two methods of haploidentical stem cell transplantation for blood cancers
A Multi-center, Prospective Study of Clinical Outcome and Immune Reconstruction in G-CSF/ATG and PT-Cy Based Haploidentical Transplantation
Peking University People's Hospital · NCT05629260
This study is testing two different methods of stem cell transplantation for blood cancers to see which one helps patients aged 18 to 55 have better outcomes and fewer complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05629260 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the incidence of relapse between two haploidentical stem cell transplantation methods: G-CSF/ATG based and PT-Cy based. It focuses on patients aged 18 to 55 years diagnosed with hematological malignancies who are undergoing unmanipulated haplo-HSCT with myeloablative conditioning. The study will also evaluate secondary outcomes such as CMV infection rates, graft-versus-host disease (GVHD), survival outcomes, and the dynamic immune reconstitution associated with each method. Additionally, it will explore the long-term quality of life of recipients under both protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with acute leukemia and no available HLA-identical donor.
Not a fit: Patients with uncontrollable active infections or severe organ impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved transplantation strategies that reduce relapse rates in patients with hematological malignancies.
How similar studies have performed: Other studies have explored haploidentical transplantation methods, but this specific comparison of G-CSF/ATG and PT-Cy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects diagnosed as acute leukemia with transplant indications in ≤ CR2; 2. Lack of available, HLA-identical, related sibling or unrelated donor; 3. Female or male, age: 18-55 years old; 4. ECOG performance status 0-2; 5. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5× upper limit of normal (ULN), or AST and ALT ≤5× ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin≤1.5× ULN Serum creatinine≤2.5× ULN 6. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment; 7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Uncontrollable active infection; 2. Severe organic impairment: hepatic and renal impairment; 3. Any of the following within 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, or cerebrovascular accident including transient ischemic attack; 4. Pregnancy or breastfeeding; 5. Psychiatric disorders; 6. Don't sign the informed consent; 7. Prior/concurrent clinical study experience; 8. Other conditions: * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6) * Any specific situation during study implementation/course that may rise ethics considerations * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
Where this trial is running
Beijing, Beijing
- People's Hospital of Peking University — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Xu Zhengli, M.D
- Email: xuzhengli0202@163.com
- Phone: 86-10-88326904
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.
Conditions: Hematological Malignancy, Haploidentical Transplantation, G-CSF/ATG, PT-Cy