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New treatment option for Acute Lymphoblastic Leukemia, Pediatric
Official title A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
ClinicalTrials.gov ID: NCT06559345
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia, pediatric.
Also referred to as CTX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
- Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
- Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the...
- Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
- Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic...
You likely can't join if
- To be eligible for inclusion in the study, participants must not meet any of the following criteria:
- The patient has not achieved hematologic remission before transplantation.
- The patient has chosen a non-haploidentical related donor.
- The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
- The patient has an active or refractory infection, or other life-threatening complications.
- The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
See the full eligibility criteria
- Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
- Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
- 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.
- Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
- Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
- 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...
- 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...
- 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.
- To be eligible for inclusion in the study, participants must not meet any of the following criteria:
- The patient has not achieved hematologic remission before transplantation.
- The patient has chosen a non-haploidentical related donor.
- The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
- The patient has an active or refractory infection, or other life-threatening complications.
- The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
- 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...
- The investigator deems the patient unsuitable for participation in the study for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.