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Recruiting NCT06250959

RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

Phase II Interventional ALL, Adult Philadelphia-Negative ALL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blinatumomab Injection [Blincyto], Doxorubicin.
Who it may be relevant to
Registry conditions: ALL, Adult, Philadelphia-Negative ALL. Basic parameters: 15 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Blinatumomab Injection [Blincyto]
    Reduced-intensity chemotherapy followed by Blinatumomab
  • Drug Doxorubicin
    HyperCVAD regimen

Primary outcome measures

  • Composite complete remission rate [Time frame: Induction therapy phase: The time of bone marrow evaluation is day 28±7.]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06250959 · BEAT-ALL-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗