Comparing two conditioning regimens for pediatric leukemia treatment
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Lymphoblastic Leukemia
This study is testing which of two treatment plans, Total Body Irradiation or Total Marrow, Central Nervous System and Lymphoid Irradiation, works better for kids with leukemia getting a stem cell transplant to help them feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06564493 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of two conditioning regimens, Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI), on pediatric patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT). The goal is to determine which regimen more effectively eliminates leukemia cells while minimizing damage to normal tissues and reducing transplant-related complications. Participants aged 1-17 years in remission will be randomly assigned to receive either TBI or TMLI, with the aim of improving survival outcomes and quality of life for these young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-17 years diagnosed with acute lymphoblastic leukemia who are in hematologic remission and have a suitable matched sibling donor.
Not a fit: Patients who are not in remission or do not have a matched sibling donor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced side effects for pediatric patients with acute lymphoblastic leukemia.
How similar studies have performed: While both TBI and TMLI regimens are supported by literature, definitive evidence favoring one over the other is lacking, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 matched sibling donoravailable, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-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. o 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-MSD 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.
Where this trial is running
Zhengzhou, Henan
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhilei Bian, PhD.
- Email: bianzhilei@sina.com
- Phone: +86037166862278
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.