Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.

Eligibility criteria

Qualifiers

Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria

CD22 positive tumor cells

≥18 years of age

Estimated survival ≥3 months

Disqualifiers

Burkitt lymphoma/leukemia

acute leukemias of ambiguous lineage

pregnant women

severe uncontrolled active infection

Trial design

Treatments tested in this trial

  • Vincristine
  • Cyclophosphamide
  • Dexamethasone
  • Venetoclax
  • Inotuzumab ozogamicin
  • Blinatumomab
  • 6-mercaptopurine
  • Methotrexate
  • Cytarabine
  • Prednisone

Treatment groups

53 Participants
are divided into 2 treatment groups