Acute Lymphoblastic LeukemiaPhase 3NCT07203352
Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
A Phase 3 study testing targeted drug in people with Acute Lymphoblastic Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This prospective, randomized, controlled trial evaluates the efficacy and safety of a new targeted drug combined with chemotherapy versus standard chemotherapy alone. Eligible patients were randomized 1:1 to either the treatment or control group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- targeted drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Dec 2026
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects were diagnosed with acute T-lymphocytic leukemia (according to the 2016 WHO classification) based on their bone marrow pathology and hematology, and sufficient bone marrow samples were available for PCR analysis;
- The subjects must have never received anti-leukemia treatment before;
- Age ≥ 18 years old, gender not restricted;
- The subjects' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- The subjects or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.
Who cannot join
- Classified as other types of leukemia according to the WHO 2016 classification;
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Had other tumors in addition to leukemia;
- Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;
- Patients with a history of allergic reactions to any drugs in this research protocol;
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- Left ventricular ejection fraction ≤ 50%;
- Laboratory test values at screening (unless caused by leukemia): ALT or AST higher than twice the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal, creatinine level higher than 1.5 times the upper limit of normal;
- Other concurrent and uncontrolled medical conditions that the researcher considers will affect the patient's participation in the study;
- Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- HIV-infected individuals.
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
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Li Xuan, 15521251270, 356135708@qq.com
About this study
Official title: Efficacy and Safety of Targeted Drugs Combined With Chemotherapy in the Treatment of Patients With Newly Diagnosed Acute T-lymphocytic Leukemia
This prospective, randomized, controlled trial evaluates the efficacy and safety of a new targeted drug combined with chemotherapy versus standard chemotherapy alone. Eligible patients were randomized 1:1 to either the treatment or control group.
Read the detailed description
This study is a prospective, randomized, controlled clinical trial aimed at evaluating the efficacy and safety of the new targeted drug combined with chemotherapy. After signing the informed consent form, patients who met the inclusion/exclusion criteria were randomly assigned to the treatment group and the control group at a ratio of 1:1. Both groups of subjects received standard induction chemotherapy in the first course. Patients in the treatment group would receive corresponding targeted drug combined chemotherapy based on bone marrow PCR testing, while patients in the control group would receive standard chemotherapy. Both the treatment group and the control group would select subsequent treatments based on the chemotherapy efficacy of the subjects. Each subject would undergo regular bone marrow examinations and other evaluations for the underlying disease on a regular basis.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- targeted drug
- 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.
targeted drugDrug
Patients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination.The subjects randomly assigned to the experimental group received targeted drug treatment in addition to the chemotherapy regimen during the second course. Based on the results of bone marrow PCR, subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day; subjects with molecular typing of FLT3-ITD positive were to receive chemotherapy combined with sorafenib 400mg orally twice a day.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The subjects randomly assigned to the experimental group received targeted drug treatment in addition to the chemotherapy regimen during the second course. Based on the results of bone marrow PCR, subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day; subjects with molecular typing of FLT3-ITD positive were to receive chemotherapy combined with sorafenib 400mg orally twice a day. Receives: Drug: targeted drug |
| control group | No intervention | Patients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2-year
Secondary outcomes (2)
Progress-free survival
Measured: 2-year
Cumulative incidence of relapse
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203352
- Sponsor's protocol ID
- NFEC-2025-241
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Targeted Drugs Combined With Chemotherapy in the Treatment of Patients With Newly Diagnosed Acute T-lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT07203352
- Acronym / sponsor ID
- NFEC-2025-241
- Conditions
- Acute Lymphoblastic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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 prospective, randomized, controlled trial evaluates the efficacy and safety of a new targeted drug combined with chemotherapy versus standard chemotherapy alone. Eligible patients were randomized 1:1 to either the treatment or control group.
Detailed description
This study is a prospective, randomized, controlled clinical trial aimed at evaluating the efficacy and safety of the new targeted drug combined with chemotherapy. After signing the informed consent form, patients who met the inclusion/exclusion criteria were randomly assigned to the treatment group and the control group at a ratio of 1:1. Both groups of subjects received standard induction chemotherapy in the first course. Patients in the treatment group would receive corresponding targeted drug combined chemotherapy based on bone marrow PCR testing, while patients in the control group would receive standard chemotherapy. Both the treatment group and the control group would select subsequent treatments based on the chemotherapy efficacy of the subjects. Each subject would undergo regular bone marrow examinations and other evaluations for the underlying disease on a regular basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: targeted drugThe subjects randomly assigned to the experimental group received targeted drug treatment in addition to the chemotherapy regimen during the second course. Based on the results of bone marrow PCR, subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day; subjects with molecular typing of FLT3-ITD positive were to receive chemotherapy combined with sorafenib 400mg orally twice a day. |
| control group | No intervention | –Patients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects were diagnosed with acute T-lymphocytic leukemia (according to the 2016 WHO classification) based on their bone marrow pathology and hematology, and sufficient bone marrow samples were available for PCR analysis;
- The subjects must have never received anti-leukemia treatment before;
- Age ≥ 18 years old, gender not restricted;
- The subjects' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- The subjects or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.
Key exclusion criteria (12 listed)
- Classified as other types of leukemia according to the WHO 2016 classification;
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Had other tumors in addition to leukemia;
- Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;
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 |
|---|---|---|
| targeted drugPatients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination.The subjects randomly assigned to the experimental group received targeted drug treatment in addition to the chemotherapy regimen during the second course. Based on the results of bone marrow PCR, subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day; subjects with molecular typing of FLT3-ITD positive were to receive chemotherapy combined with sorafenib 400mg orally twice a day. | Drug | experimental group |
Primary outcome
Overall survival
Time frame: 2-year
2 secondary outcomes
Progress-free survival
Time frame: 2-year
Cumulative incidence of relapse
Time frame: 2-year
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 2 Oct 2025.
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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.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing targeted drug in people with Acute Lymphoblastic Leukemia, run by Nanfang Hospital, Southern Medical 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 5 inclusion and 12 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 2 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Olivia Jiang (02061641611, 18956985366@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2-year). 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 2 Oct 2025.