NCT06564493 A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
| NCT ID | NCT06564493 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Zhengzhou University |
| Condition | Acute Lymphoblastic Leukemia, Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2025-03-01 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06564493 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Acute Lymphoblastic Leukemia, Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06564493 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06564493 currently recruiting?
Yes, NCT06564493 is actively recruiting participants. Contact the research team at bianzhilei@sina.com for enrollment information.
Where is the NCT06564493 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06564493 clinical trial?
NCT06564493 is sponsored by The First Affiliated Hospital of Zhengzhou University. The trial plans to enroll 170 participants.
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