B ALLPhase 3NCT07441291
CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
A Phase 3 study testing CAR-T and DLI in people with B ALL and Allogenetic Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 1 site in China.
Trial summary
This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic… Read more about this study
- Who is it for?
- Ages 3 to 79 years
- Conditions the study is for
- B ALL, Allogenetic Hematopoietic Stem Cell Transplantation, MRD-positive
- What is being tested?
- CAR-T and DLI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Dec 2028
- 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 3 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 3-<80 years
- ECOG performance status 0-2
- post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
- no hematological/extramedullary relapse
- adequate organ function
- negative pregnancy test (for fertile females)
Who cannot join
- active infections
- uncontrolled graft-versus-host disease (GVHD)
- history of central nervous system disorders
- autoimmune diseases
- other active malignancies
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
Peking University People's Hospital
Beijing, China, 100044
Jing Liu, 8610-88326900, greenimp@163.com
About this study
Official title: CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial
This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).
Patients (aged 3-<80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.
Read more
The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity.
The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
Read the detailed description
Objective: This prospective, open-label, randomized controlled trial (RCT) aims to compare the efficacy and safety of CD19 chimeric antigen receptor T-cell (CAR-T) therapy versus chemotherapy plus donor lymphocyte infusion (DLI) in patients with Ph-negative acute B-lymphoblastic leukemia (Ph- B-ALL) positive for minimal residual disease (MRD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Study Population: A total of 70 eligible patients will be randomized 1:1 to the experimental group (CD19 CAR-T, n=35) or control group (chemotherapy + DLI, n=35).
Interventions:
Experimental group: Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.
Control group: Chemotherapy combined with DLI.
Study Endpoints:
Primary endpoint: MRD negativity rate at 3 months post-treatment. Secondary endpoints: 1-year MRD positivity rate, hematological/extramedullary relapse rate, overall survival (OS), disease-free survival (DFS), incidence of grade II-IV acute GVHD (aGVHD), NIH moderate-to-severe chronic GVHD (cGVHD), graft-versus-host disease-free relapse-free survival (GRFS), and duration of grade III-IV hematological toxicity.
Study Duration: Enrollment starts with the first patient's treatment; study conclusion is 1 year after the last patient's treatment. Efficacy assessments are conducted at 1, 2, 3, 4, 5, 6, 9, and 12 months post-treatment.
Crossover Design: Patients with persistent MRD (≥0.1%) at 3 months without relapse may crossover: experimental group to chemotherapy + DLI, control group to CD19 CAR-T therapy (with informed consent).
Statistical Analysis: Sample size is calculated based on a superior design (90% vs 60% 3-month MRD negativity rate in CAR-T vs control group; α=0.05, β=0.2, 10% dropout rate). Categorical variables are summarized as counts/proportions (95% CI); continuous variables as mean/median (SD/range). Survival data (OS, DFS) will be analyzed using Kaplan-Meier methods and log-rank tests.
- Being tested
- CAR-T, DLI
- Keywords
- CD19 CAR-T, Donor Lymphocyte Infusion (DLI), Ph-negative B-ALL, Minimal Residual Disease (MRD), Hematopoietic Stem Cell Transplantation (HSCT)
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TBiological
Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.
DLIBiological
Chemotherapy combined with DLI
| Study group | Role | What they receive |
|---|---|---|
| CAR-T group | Experimental | Autologous CD19 CAR-T (1.0×10⁶/kg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo). Receives: Biological: CAR-T |
| Control group | Active comparator | Chemotherapy + DLI Receives: Biological: DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month MRD negativity rate
MRD negativity rate of MFC
Measured: 3-month
Secondary outcomes (7)
1-year MRD negativity rate
1-year MRD negativity rate of MFC
Measured: 1-year
relapse rate
relapse rate of leukemia
Measured: 1-year
OS
overall survival
Measured: 1-year
DFS
Disease free survival
Measured: 1-year
GVHD incidence
the rate and degree of aute and chronic graft versus host disease
Measured: 1-year
GRFS
GVHD and relapse free survival
Measured: 1-year
grade III-IV hematological toxicity duration
grade III-IV hematological toxicity duration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Nov 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B ALLStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI. The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441291
- Sponsor's protocol ID
- CD19 CAR-T vs DLI for MRD
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07441291
- Acronym / sponsor ID
- CD19 CAR-T vs DLI for MRD
- Keywords
- CD19 CAR-T, Donor Lymphocyte Infusion (DLI), Ph-negative B-ALL, Minimal Residual Disease (MRD), Hematopoietic Stem Cell Transplantation (HSCT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 27 Feb 2026 (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, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).
Patients (aged 3-<80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.
The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity.
The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
Detailed description
Objective: This prospective, open-label, randomized controlled trial (RCT) aims to compare the efficacy and safety of CD19 chimeric antigen receptor T-cell (CAR-T) therapy versus chemotherapy plus donor lymphocyte infusion (DLI) in patients with Ph-negative acute B-lymphoblastic leukemia (Ph- B-ALL) positive for minimal residual disease (MRD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Study Population: A total of 70 eligible patients will be randomized 1:1 to the experimental group (CD19 CAR-T, n=35) or control group (chemotherapy + DLI, n=35).
Interventions:
Experimental group: Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.
Control group: Chemotherapy combined with DLI.
Study Endpoints:
Primary endpoint: MRD negativity rate at 3 months post-treatment. Secondary endpoints: 1-year MRD positivity rate, hematological/extramedullary relapse rate, overall survival (OS), disease-free survival (DFS), incidence of grade II-IV acute GVHD (aGVHD), NIH moderate-to-severe chronic GVHD (cGVHD), graft-versus-host disease-free relapse-free survival (GRFS), and duration of grade III-IV hematological toxicity.
Study Duration: Enrollment starts with the first patient's treatment; study conclusion is 1 year after the last patient's treatment. Efficacy assessments are conducted at 1, 2, 3, 4, 5, 6, 9, and 12 months post-treatment.
Crossover Design: Patients with persistent MRD (≥0.1%) at 3 months without relapse may crossover: experimental group to chemotherapy + DLI, control group to CD19 CAR-T therapy (with informed consent).
Statistical Analysis: Sample size is calculated based on a superior design (90% vs 60% 3-month MRD negativity rate in CAR-T vs control group; α=0.05, β=0.2, 10% dropout rate). Categorical variables are summarized as counts/proportions (95% CI); continuous variables as mean/median (SD/range). Survival data (OS, DFS) will be analyzed using Kaplan-Meier methods and log-rank tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI. The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
| Arm | Type | Receives |
|---|---|---|
| CAR-T group | Experimental | Biological: CAR-TAutologous CD19 CAR-T (1.0×10⁶/kg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo). |
| Control group | Active comparator | Biological: DLIChemotherapy + DLI |
Who may qualify
- Ages
- 3 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age 3-<80 years
- ECOG performance status 0-2
- post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
- no hematological/extramedullary relapse
- adequate organ function
Key exclusion criteria (5 listed)
- active infections
- uncontrolled graft-versus-host disease (GVHD)
- history of central nervous system disorders
- autoimmune diseases
- other active malignancies
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 |
|---|---|---|
| CAR-TAutologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed. | Biological | CAR-T group |
| DLIChemotherapy combined with DLI | Biological | Control group |
Primary outcome
3-month MRD negativity rate
Time frame: 3-month
MRD negativity rate of MFC
7 secondary outcomes
1-year MRD negativity rate
Time frame: 1-year
relapse rate
Time frame: 1-year
OS
Time frame: 1-year
DFS
Time frame: 1-year
GVHD incidence
Time frame: 1-year
GRFS
Time frame: 1-year
grade III-IV hematological toxicity duration
Time frame: 3 months
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 CAR-T and DLI in people with B ALL and Allogenetic Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital 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 6 inclusion and 5 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 27 Feb 2026. 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 Jing Liu, Doctor (8610-88326900, greenimp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month MRD negativity rate (time frame: 3-month). 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 27 Feb 2026.