The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to a type of stem cell transplant called haploidentical transplantation, which is used for patients with blood cancers like leukemia. The study aims to find out which method—G-CSF/ATG or PT-Cy—leads to fewer relapses of the cancer after the transplant. It will also look at other important factors, such as the risk of infections, side effects, and overall survival rates, as well as how the immune system recovers after the procedure.

To participate, patients need to be between 18 and 55 years old and have a diagnosis of acute leukemia that requires a transplant, but without an available matched donor. They should also have good organ function and be able to attend follow-up visits. Participants will receive close monitoring throughout the study, and their quality of life will be assessed over time. This trial is currently recruiting participants, and those interested will need to provide informed consent to join.

Gender

ALL

Eligibility 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.