High Risk Acute Lymphoblastic LeukemiaPhase 2NCT06438796
Blinatumomab Maintenance After Allo-HSCT
A Phase 2 study testing Blinatumomab in people with High Risk Acute Lymphoblastic Leukemia, run by Ruijin Hospital.
Trial summary
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- High Risk Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2028
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-65 years
- Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
- High-risk group B-ALL
- Have suitable hematopoietic stem cell donors
- No dysfunction of vital organs
Who cannot join
- CR/MRD negative before blinatumomab maintenance
- Active hepatitis B
- HIV-infected
- Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
- severe impairment of vital organ function
- Those judged by the investigator to be unsuitable for participation in this trial.
About this study
Official title: Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia: a Multicenter, Open-label, Randomized Controlled Study
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
Read the detailed description
Blinatumomab is a novel immunological antibody based on BiTE. CD19 is a surface antigen expressed throughout the development of B lymphocytes, making it an ideal target for immunotherapy. Blinatumomab was approved by the FDA for the treatment of adults with relapsed/refractory cancers. Open-label, single-arm, multicenter phase II clinical study (BLAST study) , enrolling 116 adult patients with precursor B-ALL in complete hematologic remission after at least 3 doses of intense chemotherapy but persistently positive for Measurable Residual Disease (MRD) (MRD ≥10-3 ), which is the first ALL international multicenter clinical trial. In August 2022, China's National Medicines and Pharmaceutical Administration (NMPA) Approved Blinatumomab for the treatment of relapsed/refractory precursor B-cell ALL in adults.
Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion, and fewer prospective studies have been conducted in the area of maintenance therapy. A prospective single-arm clinical study (NCT02807883) with Blinatumomab as maintenance therapy (up to 4 cycles) after allogeneic transplantation, concluded by MD Anderson in August 2021, had the primary endpoints of safety (acute graft-versus-host disease [aGVHD] and non-relapse mortality [NRM]) and the secondary endpoints of efficacy (PFS, OS, etc.), a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab, the interval between transplantation and the first cycle of Blinatumomab use was 78 days (44-105), 57% of the patients completed 4 cycles of treatment, the median follow-up was 14.3 months, the 1-year NRM was 0%, the incidence of grade 3-4 aGVHD was 5%, the 1-year OS was 85%, and the 1-year PFS was 71%. There was a trend toward benefit in PFS and OS curves between the two groups. Although this study is an exploratory study, data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new, better and safer option.
Therefore, the investigators conducted a multicenter, randomized, controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation.
- Conditions
- High Risk Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Maintenance therapy with Blinatumomab initiation: 90 days to 120 days post-transplantation
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab group | Experimental | Blinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d) Receives: Drug: Blinatumomab |
| Control group | No intervention | Maintenance therapy in the control group was based on the routine maintenance therapy in each center (including but not limited to decitabine, sorafenib, prophylactic DLI, except for all types of CD19 mono- and dual-antibodies and CD22-ADC drugs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Event-free survival
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
2-year relapse rate
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xiaoxia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438796
- Sponsor's protocol ID
- TROPHY-ALL01
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia: a Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06438796
- Acronym / sponsor ID
- TROPHY-ALL01
- Conditions
- High Risk Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Jun 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.
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
Detailed description
Blinatumomab is a novel immunological antibody based on BiTE. CD19 is a surface antigen expressed throughout the development of B lymphocytes, making it an ideal target for immunotherapy. Blinatumomab was approved by the FDA for the treatment of adults with relapsed/refractory cancers. Open-label, single-arm, multicenter phase II clinical study (BLAST study) , enrolling 116 adult patients with precursor B-ALL in complete hematologic remission after at least 3 doses of intense chemotherapy but persistently positive for Measurable Residual Disease (MRD) (MRD ≥10-3 ), which is the first ALL international multicenter clinical trial. In August 2022, China's National Medicines and Pharmaceutical Administration (NMPA) Approved Blinatumomab for the treatment of relapsed/refractory precursor B-cell ALL in adults.
Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion, and fewer prospective studies have been conducted in the area of maintenance therapy. A prospective single-arm clinical study (NCT02807883) with Blinatumomab as maintenance therapy (up to 4 cycles) after allogeneic transplantation, concluded by MD Anderson in August 2021, had the primary endpoints of safety (acute graft-versus-host disease [aGVHD] and non-relapse mortality [NRM]) and the secondary endpoints of efficacy (PFS, OS, etc.), a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab, the interval between transplantation and the first cycle of Blinatumomab use was 78 days (44-105), 57% of the patients completed 4 cycles of treatment, the median follow-up was 14.3 months, the 1-year NRM was 0%, the incidence of grade 3-4 aGVHD was 5%, the 1-year OS was 85%, and the 1-year PFS was 71%. There was a trend toward benefit in PFS and OS curves between the two groups. Although this study is an exploratory study, data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new, better and safer option.
Therefore, the investigators conducted a multicenter, randomized, controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab group | Experimental | Drug: BlinatumomabBlinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d) |
| Control group | No intervention | –Maintenance therapy in the control group was based on the routine maintenance therapy in each center (including but not limited to decitabine, sorafenib, prophylactic DLI, except for all types of CD19 mono- and dual-antibodies and CD22-ADC drugs). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 16-65 years
- Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
- High-risk group B-ALL
- Have suitable hematopoietic stem cell donors
- No dysfunction of vital organs
Key exclusion criteria (6 listed)
- CR/MRD negative before blinatumomab maintenance
- Active hepatitis B
- HIV-infected
- Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
- severe impairment of vital organ function
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 |
|---|---|---|
| BlinatumomabMaintenance therapy with Blinatumomab initiation: 90 days to 120 days post-transplantation | Drug | Blinatumomab group |
Primary outcome
2-year Event-free survival
Time frame: through study completion, an average of 2 year
1 secondary outcome
2-year relapse rate
Time frame: through study completion, an average of 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 3 Jun 2024.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab in people with High Risk Acute Lymphoblastic Leukemia, run by Ruijin Hospital.
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 6 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: opening soon, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Event-free survival (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438796, which also lists 1 linked publication.
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 3 Jun 2024.