Actively Recruiting
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-02-18
170
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.
CONDITIONS
Official Title
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign a written informed consent form.
- Participants are male or female, aged 18 to 65 years inclusive.
- Must be diagnosed with acute lymphoblastic leukemia (ALL) according to WHO criteria.
- Leukemia must be in hematologic complete remission before transplantation.
- A suitable matched sibling donor must be available, and participant must consent to MSD hematopoietic stem cell transplantation.
- Karnofsky Performance Status of 70 or higher.
- Cardiac function classified as New York Heart Association class II or lower.
- Liver enzymes (ALT and AST) no more than 2.5 times the upper normal limit; bilirubin no more than 2 times the upper normal limit.
- Serum creatinine no more than 1.5 times the upper normal limit or creatinine clearance rate at least 60 ml/min.
- No significant dyspnea, no need for oxygen therapy, no interstitial lung disease, and no active pulmonary infections.
- Women of childbearing potential must test negative for pregnancy at screening and baseline and agree to use effective contraception for at least one year after transplantation.
- Male participants with female partners of childbearing potential must agree to use barrier contraception and avoid sperm donation for at least one year after transplantation.
You will not qualify if you...
- Not in hematologic remission before transplantation.
- Use of a non-matched sibling donor.
- Severe cardiac, hepatic, renal, or pulmonary diseases preventing tolerance to conditioning regimen.
- Active or refractory infection or other life-threatening complications.
- History of other malignant tumors, psychiatric disorders, or HIV infection.
- Refusal to sign informed consent, unwillingness to comply with follow-up, or refusal to allow use of data for future research.
- Investigator deems the participant unsuitable for any other reason.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450001
Actively Recruiting
Research Team
Z
Zhilei Bian, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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