A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Registration Number
- NCT06557161
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria:<br><br> 1. Informed Consent: Participants must voluntarily sign a written informed consent<br> form.<br><br> 2. Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.<br><br> 3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL)<br> according to World Health Organization (WHO) criteria, and the diagnosis must apply<br> to adults aged 18-65 years.<br><br> 4. Remission Status: The participant's leukemia must be in hematologic remission<br> (complete remission, CR) prior to transplantation.<br><br> 5. Donor Availability: There must be a suitable mathced sibling donor available, and<br> the participant must consent to undergo MSD hematopoietic stem cell transplantation<br> (MSD-HSCT).<br><br> 6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or<br> higher, indicating that they are capable of caring for themselves and carrying out<br> normal activities. Additionally, they must not have significant organ dysfunction,<br> defined by the following:<br><br> - Cardiac Function: New York Heart Association (NYHA) classification of class II<br> or lower.<br><br> - Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase<br> (AST) levels should be no more than 2.5 times the upper limit of normal.<br> Bilirubin levels should be no more than 2 times the upper limit of normal.<br><br> - Renal Function: Serum creatinine levels should be no more than 1.5 times the<br> upper limit of normal, or the creatinine clearance rate should be at least 60<br> ml/min.<br><br> - Pulmonary Function: Participants should not experience significant dyspnea,<br> should not require oxygen therapy, should not have interstitial lung disease,<br> and should not have any active pulmonary infections.<br><br> 7. Reproductive Health:<br><br> - Women of childbearing potential must test negative for pregnancy with a Human<br> Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both<br> screening and baseline periods. They must also agree to use effective<br> contraception for at least one year following the transplantation.<br><br> - Male participants with female partners of childbearing potential must agree to<br> use effective barrier contraception and refrain from sperm donation for at<br> least one year following the transplantation.<br><br>Exclusion Criteria: To be eligible for inclusion in the study, participants must not meet<br>any of the following criteria:<br><br> 1. The patient has not achieved hematologic remission before transplantation.<br><br> 2. The patient has chosen a non-MSD donor.<br><br> 3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them<br> unable to tolerate the conditioning regimen.<br><br> 4. The patient has an active or refractory infection, or other life-threatening<br> complications.<br><br> 5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV<br> infection.<br><br> 6. The patient refuses to sign the informed consent form, is unwilling to comply with<br> clinical follow-up required by the study, or does not consent to the use of their<br> data to support future research, project presentations, and clinical practices.<br><br> 7. The investigator deems the patient unsuitable for participation in the study for any<br> other reason.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS);acute Graft Versus Host Disease (aGVHD);Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Transplantation Related Mortality (TRM);Relapse Rate (RR);Conditioning-related Adverse Events (CRAE)