A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Aug 15, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring two different treatments for adults with acute lymphoblastic leukemia (ALL) who are preparing for a special type of transplant called matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT). The study is comparing two conditioning regimens: Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Researchers believe that TMLI might be better at killing leukemia cells while causing less harm to healthy tissues, which could lead to fewer side effects and better outcomes for patients.

To participate in this trial, individuals need to be between 18 and 65 years old, have been diagnosed with ALL and be in remission, and have a suitable sibling donor available. Participants should also be in generally good health, able to take care of themselves, and agree to follow the study's guidelines. Those who join can expect regular check-ups and support throughout the process as researchers gather information to help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed Consent: Participants must voluntarily sign a written informed consent form.
• • 2. Age and Gender: Participants should be male or female, aged 18-65 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 adults aged 18-65 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 mathced sibling donor available, 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.
• • 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.
• 7. 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 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 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.
• • 7. The investigator deems the patient unsuitable for participation in the study for any other reason.