Status:
RECRUITING
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 transplan...
Eligibility Criteria
Inclusion
- Informed Consent: Participants must voluntarily sign a written informed consent form.
- Age and Gender: Participants should be male or female, aged 18-65 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 adults aged 18-65 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 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.
- Reproductive Health:
- Women of childbearing potential must test negative for pregnancy with a Human Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both screening and baseline periods. They must also agree to use effective contraception for at least one year following the transplantation.
- Male participants with female partners of childbearing potential must agree to use effective barrier contraception and refrain from sperm donation for at least one year following the transplantation.
Exclusion
- 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 patient 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.
- The investigator deems the patient unsuitable for participation in the study for any other reason.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06564545
Start Date
March 1 2025
End Date
December 31 2029
Last Update
February 18 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450001