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B Acute Lymphoblastic LeukemiaPhase 2NCT05557110

Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL

A Phase 2 study testing Blinatumomab in people with B Acute Lymphoblastic Leukemia, run by Chen Suning at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
B Acute Lymphoblastic Leukemia
What is being tested?
Blinatumomab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
8 Sep 2022to 31 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 and known ABL class Ph-Like ALL
  • T cells ALL
  • Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
  • Acute mixed-cell leukemia
  • Central nervous system leukemia
  • HIV infection
Show all 10Show fewer
  • 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.

China1 site

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia

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 treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.

Being tested
Blinatumomab
Keywords
Blinatumomab, Ph-B-ALL, Induction therapy
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BlinatumomabDrug

    Reduced-intensity chemotherapy followed by Blinatumomab

Study groups in NCT05557110
Study groupRoleWhat they receive
reduced-intensity chemotherapy followed by berintuzumabExperimentalInduction therapy was performed with reduced intensity chemotherapy (including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vindesine 3 mg/m2, 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. Bone marrow evaluation was performed on day 22±2, and consolidation therapy was performed after achieving bone marrow remission (CR/CRh/CRi). If CR/CRh/CRi was not achieved in the first course of induction therapy, Blinatumomab (28ug/d×14d) should be continued and bone marrow evaluation should be evaluated again. 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.
Receives: Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Overall response rate (ORR), including complete response (CR)/ complete response rate with partial hematologic recovery (CRh)/ complete response rate with incomplete hematologic recovery (CRi).

    Measured: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.

Secondary outcomes (5)

  1. 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 22 or 37±2.

  2. Treatment-related SAE

    Incidence of treatment-related severe adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.

    Measured: From the beginning of induction therapy to the beginning of consolidation therapy.

  3. Time of hematopoietic recovery

    The duration of the patient in the granulocytic deficiency and thrombocytopenia phases.

    Measured: From the beginning of induction therapy to the beginning of consolidation therapy.

  4. Event-free survival (EFS)

    The time from enrollment to the occurrence of any event, including death, progression of disease, change in treatment regimen, and occurrence of fatal or intolerable side effects.

    Measured: 1 year after study completion

  5. 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.

  1. First posted27 Sep 2022
  2. Study start8 Sep 2022
  3. Primary completion5 Jan 2024
  4. Study completion31 Mar 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557110
Sponsor's protocol ID
SZ-ALL02
Status last verified
Sep 2024
First submitted
16 Sep 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu J, Qiu H, Wang Y, Zhou X, Dai H, Lu X, Yang X, Gu B, Hong M, Miao M, Lu R, Wang J, Wu Q, Xue M, Wang Y, Deng A, Shen Y, Liu Y, Dou X, Lei Y, Wu D, Zhu Y, Chen S. Reduced-dose chemotherapy and blinatumomab as induction treatment for newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia: a phase 2 trial. J Hematol Oncol. 2024 Sep 2;17(1):79. doi: 10.1186/s13045-024-01597-8.

    PubMed 39218935

  • Lu J, Zhu Y, Qiu H, Wang Y, Zhou X, Dai H, Lu X, Gu B, Hong M, Miao M, Lu R, Wang J, Wu Q, Xue M, Wang Y, Deng A, Shen Y, Liu Y, Dou X, Lei Y, Yang X, Chen S. Reduced-dose chemotherapy followed by blinatumomab for newly diagnosed philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia: a propensity-matched comparison with hyper-CVAD. Discov Oncol. 2025 Feb 21;16(1):223. doi: 10.1007/s12672-025-01968-8.

    PubMed 39984805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinatumomab in people with B Acute Lymphoblastic Leukemia, 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: finished, as of the sponsor's last update on 19 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (ORR) (time frame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.). 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 NCT05557110, which also lists 2 linked publications.

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 19 Sep 2024.

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