Comparing two conditioning regimens for stem cell transplantation in adult leukemia patients

A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Adult Acute Lymphoblastic Leukemia

This study is testing which of two radiation treatments helps adults with leukemia do better after getting a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06564545 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of two conditioning regimens, Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI), on adults with acute lymphoblastic leukemia (ALL) undergoing haploidentical stem cell transplantation. The study aims to determine which regimen more effectively eliminates leukemia cells while minimizing damage to normal tissues. Participants will be randomly assigned to receive either TBI or TMLI, with the goal of improving survival outcomes and quality of life. The trial is designed to provide evidence for the optimal conditioning approach in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 years diagnosed with acute lymphoblastic leukemia in remission and with a suitable haploidentical donor.

Not a fit: Patients outside the age range of 18-65 years or those not in remission may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for adult patients with acute lymphoblastic leukemia undergoing stem cell transplantation.

How similar studies have performed: While both TBI and TMLI regimens are supported by literature, this study aims to provide definitive evidence comparing their effectiveness, making it a novel approach.

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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Xiangbo Wan, PhD. — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Zhilei Bian, PhD.

Conditions Acute Lymphoblastic Leukemia, Adult