A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for children with acute lymphoblastic leukemia (ALL) who need a special type of stem cell transplant called haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The researchers want to see if using Total Body Irradiation (TBI) or Total Marrow, Central Nervous System, and Lymphoid Irradiation (TMLI) as a preparatory treatment can better eliminate leukemia cells while causing less harm to healthy tissues. The goal is to find the best way to improve the chances of recovery and quality of life for young patients with ALL.

To participate in this trial, children aged 1 to 17 years who have been diagnosed with ALL and are in remission may qualify. They need to have a suitable donor and must be in good overall health, meaning they can care for themselves and have no serious organ issues. Participants will undergo the chosen treatment regimen and will be closely monitored throughout the process. This study is currently recruiting, and it aims to provide valuable information that could help improve future treatments for pediatric ALL patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
• • 2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
• • 3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.
• • 4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
• • 5. Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
• 6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:
• • Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.
• • Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.
• • Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml/min.
• • Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.
• Exclusion Criteria:
• To be eligible for inclusion in the study, participants must not meet any of the following criteria:
• • 1. The patient has not achieved hematologic remission before transplantation.
• • 2. The patient has chosen a non-haploidentical related donor.
• • 3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
• • 4. The patient has an active or refractory infection, or other life-threatening complications.
• • 5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
• • 6. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.
• • 7. The investigator deems the patient unsuitable for participation in the study for any other reason.