A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
NCT ID: NCT06557161
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2025-03-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TMLI conditioning group
Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide
TMLI
The total dose of TMLI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
Cyclophosphamide
The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
TBI conditioning group
Total Body Irradiation (TBI) plus Cyclophosphamide
TBI
The total dose of TBI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
Cyclophosphamide
The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
Interventions
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TBI
The total dose of TBI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
TMLI
The total dose of TMLI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.
Cyclophosphamide
The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Xiangbo Wan
Professor
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Wan Xiangbo Xiangbo Wan
Role: primary
Other Identifiers
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2024-KY-0211
Identifier Type: -
Identifier Source: org_study_id
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