Actively Recruiting
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-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
276
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 haploidentical allogeneic hematopoietic stem cell transplantation (haplo-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 haplo-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 Haplo-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.
- Male or female aged 18 to 65 years.
- Diagnosed with acute lymphoblastic leukemia (ALL) according to WHO criteria.
- Leukemia must be in hematologic complete remission before transplantation.
- Suitable haploidentical donor available and consent for haplo-HSCT.
- Karnofsky performance score of 70 or higher.
- Cardiac function NYHA class II or lower.
- Liver enzymes (ALT, AST) no more than 2.5 times upper limit of normal; bilirubin no more than 2 times upper limit.
- Serum creatinine no more than 1.5 times upper limit of normal or creatinine clearance rate at least 60 ml/min.
- No significant dyspnea, no oxygen therapy needed, no interstitial lung disease, and no active lung infection.
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception for at least one year post-transplant.
- Male participants with partners of childbearing potential must agree to use barrier contraception and avoid sperm donation for at least one year post-transplant.
You will not qualify if you...
- Not in hematologic remission prior to transplantation.
- Using a non-haploidentical related donor.
- Severe cardiac, liver, kidney, or lung diseases making conditioning intolerable.
- Active or refractory infections or other life-threatening complications.
- History of other cancers, psychiatric disorders, or HIV infection.
- Refusal to sign informed consent or unwillingness to comply with study follow-up.
- Does not consent to use of data for research and clinical purposes.
- Investigator's judgment of unsuitability for participation for any other reason.
AI-Screening
AI-Powered 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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