ALL, AdultPhase 2BEAT-ALL-2024NCT06250959
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
A Phase 2 study testing Blinatumomab Injection [Blincyto] and Doxorubicin in people with ALL, Adult and Philadelphia-Negative ALL, run by Chen Suning at 1 site in China.
Trial summary
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- ALL, Adult, Philadelphia-Negative ALL
- What is being tested?
- Blinatumomab Injection [Blincyto] and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 31 Dec 2026
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
- Renal function: endogenous creatinine clearance ≧30ml/min
- Patients must be able to understand and willing to participate in the study and must sign the informed consent form.
Who cannot join
- Ph+ (BCR-ABL1 positive) ALL
- T cells ALL
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
- HIV infection
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- HBV-DNA or HCV-RNA positive
- Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
- Pregnant or breastfeeding patients
- The study patient was refused enrollment
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 Soochow University
Suzhou, Jiangsu, 215000
Jing Lu, 1377183627, lujing@suda.edu.cn
About this study
Official title: Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
Read the detailed description
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.
- Conditions
- ALL, Adult, Philadelphia-Negative ALL
- Being tested
- Blinatumomab Injection [Blincyto], Doxorubicin
- 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.
Blinatumomab Injection [Blincyto]Drug
Reduced-intensity chemotherapy followed by Blinatumomab
DoxorubicinDrug
HyperCVAD regimen
| Study group | Role | What they receive |
|---|---|---|
| Reduced-dose Chemotherapy Followed by Blinatumomab | Experimental | Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2[max 2mg], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued. Receives: Drug: Blinatumomab Injection [Blincyto] |
| hyperCVAD | Active comparator | CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14 Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete remission rate
CR/CRi
Measured: Induction therapy phase: The time of bone marrow evaluation is day 28±7.
Secondary outcomes (5)
The negative rate of minimal residual lesion (MRD)
The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10^-4)
Measured: Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
Treatment-related AE
Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.
Measured: Induction therapy phase
Quality of survival of patients in the induction therapy phase
QLQ-C30 Survival Quality Scale
Measured: Induction therapy phase
Progression-free survival（PFS）
The time from random assignment in a clinical trial to disease progression or death from any cause.
Measured: 1 year after study completion
Overall survival (OS)
From the time of enrollment in the study to the time of death from any cause.
Measured: 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start5 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, AdultStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Suning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Jing Lu, MD, Principal investigator, Soochow U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250959
- Sponsor's protocol ID
- BEAT-ALL-2024
- Acronym
- BEAT-ALL-2024
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Basic Statistical Analysis
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
- ClinicalTrials.gov ID
- NCT06250959
- Acronym / sponsor ID
- BEAT-ALL-2024 / BEAT-ALL-2024
- Conditions
- ALL, Adult, Philadelphia-Negative ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Chen SuningUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 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.
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
Detailed description
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced-dose Chemotherapy Followed by Blinatumomab | Experimental | Drug: Blinatumomab Injection [Blincyto]Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2[max 2mg], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued. |
| hyperCVAD | Active comparator | Drug: DoxorubicinCTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
Key exclusion criteria (10 listed)
- Ph+ (BCR-ABL1 positive) ALL
- T cells ALL
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
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 |
|---|---|---|
| Blinatumomab Injection [Blincyto]Reduced-intensity chemotherapy followed by Blinatumomab | Drug | Reduced-dose Chemotherapy Followed by Blinatumomab |
| DoxorubicinHyperCVAD regimen | Drug | hyperCVAD |
Primary outcome
Composite complete remission rate
Time frame: Induction therapy phase: The time of bone marrow evaluation is day 28±7.
CR/CRi
5 secondary outcomes
The negative rate of minimal residual lesion (MRD)
Time frame: Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
Treatment-related AE
Time frame: Induction therapy phase
Quality of survival of patients in the induction therapy phase
Time frame: Induction therapy phase
Progression-free survival（PFS）
Time frame: 1 year after study completion
Overall survival (OS)
Time frame: 1 year after study completion
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 4 Apr 2024.
- Individual participant dataSharing planned: Yes. Study Protocol, Basic Statistical Analysis
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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.
Jing Lu, MD principal investigator
Soochow U
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 Blinatumomab Injection [Blincyto] and Doxorubicin in people with ALL, Adult and Philadelphia-Negative ALL, run by Chen Suning 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 7 inclusion and 10 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 4 Apr 2024. 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 Jing Lu (1377183627, lujing@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complete remission rate (time frame: Induction therapy phase: The time of bone marrow evaluation is day 28±7.). 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 4 Apr 2024.