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

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out how two different treatment methods affect adults with acute lymphoblastic leukemia (ALL) who are undergoing a type of stem cell transplant known as haploidentical stem cell transplantation (haplo-HSCT). The two methods being compared are Total Body Irradiation (TBI) and Total Marrow, Central Nervous System, and Lymphoid Irradiation (TMLI). Researchers believe that TMLI might be better at targeting leukemia cells while causing less harm to healthy tissues, which could improve patients' chances of recovery and overall quality of life.

To participate in this trial, you need to be an adult between the ages of 18 and 65, diagnosed with ALL and in remission before the transplant. You’ll also need to have a suitable donor who is a close match. If you join the study, you can expect to receive one of the two treatment methods and will be closely monitored throughout the process. It's important to discuss any potential health issues with your doctor, as certain medical conditions may prevent you from participating. This study aims to provide valuable insights that could help improve treatment options for ALL 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 haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-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-haploidentical related 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.