Acute Lymphoblastic Leukemia, PediatricPhase 2NCT06559345
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
A Phase 2 study testing TMLI, TBI and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, Pediatric, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- TMLI, TBI and Cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
- Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
- Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.
- Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
- Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
- 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:
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- 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.
Who cannot join
- To be eligible for inclusion in the study, participants must not meet any of the following criteria:
- The patient has not achieved hematologic remission before transplantation.
- The patient has chosen a non-haploidentical related donor.
- The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
- The patient has an active or refractory infection, or other life-threatening complications.
- The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
- The patients or guardians 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.
- The investigator deems the patient unsuitable for participation in the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450001
Wan Xiangbo Xiangbo Wan, 86-037167963114, wanbo@zzu.edu.cn
About this study
Official title: A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Acute Lymphoblastic Leukemia
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 pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- TMLI, TBI, Cyclophosphamide
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMLIRadiation
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.
TBIRadiation
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.
CyclophosphamideDrug
Also called CTX
The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.
| Study group | Role | What they receive |
|---|---|---|
| TMLI conditioning group | Experimental | Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide Receives: Radiation: TMLI; Drug: Cyclophosphamide |
| TBI conditioning group | Active comparator | Total Body Irradiation (TBI) plus Cyclophosphamide Receives: Radiation: TBI; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint.
Measured: 2 years
acute Graft Versus Host Disease (aGVHD)
The incidence of aGVHD within 100 days post-transplant.
Measured: 100 days
Overall Survival (OS)
OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.
Measured: 2 years
Secondary outcomes (3)
Transplantation Related Mortality (TRM)
The incidence of TRM in 2 years.
Measured: 100 days
Relapse Rate (RR)
The incidence ratio of leukemia relapse in 2 years.
Measured: 2 years
Conditioning-related Adverse Events (CRAE)
Based on CTCAE v5.0.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start17 Mar 2025 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangbo Wan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xiangbo Wan, PhD., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559345
- Sponsor's protocol ID
- 2024-KY-0212
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06559345
- Acronym / sponsor ID
- 2024-KY-0212
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMLI conditioning group | Experimental | Radiation: TMLI, Drug: CyclophosphamideTotal Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide |
| TBI conditioning group | Active comparator | Radiation: TBI, Drug: CyclophosphamideTotal Body Irradiation (TBI) plus Cyclophosphamide |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
- Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
- Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.
- Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
- Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
Key exclusion criteria (8 listed)
- To be eligible for inclusion in the study, participants must not meet any of the following criteria:
- The patient has not achieved hematologic remission before transplantation.
- The patient has chosen a non-haploidentical related donor.
- The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
- The patient has an active or refractory infection, or other life-threatening complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMLIThe 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. | Radiation | TMLI conditioning group |
| TBIThe 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. | Radiation | TBI conditioning group |
| CyclophosphamideAlso: CTXThe total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3. | Drug | TBI conditioning group, TMLI conditioning group |
Primary outcome
Relapse-free survival (RFS)
Time frame: 2 years
RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint.
acute Graft Versus Host Disease (aGVHD)
Time frame: 100 days
The incidence of aGVHD within 100 days post-transplant.
Overall Survival (OS)
Time frame: 2 years
OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.
3 secondary outcomes
Transplantation Related Mortality (TRM)
Time frame: 100 days
Relapse Rate (RR)
Time frame: 2 years
Conditioning-related Adverse Events (CRAE)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangbo Wan, PhD. principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMLI, TBI and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, Pediatric, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhilei Bian, PhD. (+86037166862278, bianzhilei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.