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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06387121
Phase
PHASE2
Status
Recruiting
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Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    Anti-tumor alkaloids
  • Cyclophosphamide — DRUG
    Alkylating agent
  • Dexamethasone — DRUG
    Glucocorticoids
  • Venetoclax — DRUG
    Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
  • Inotuzumab ozogamicin — DRUG
    A humanized monoclonal antibody-drug conjugate targeting CD22
  • Blinatumomab — DRUG
    Bi-specific anti-CD19/CD3 antibodies
  • 6-mercaptopurine — DRUG
    Cell cycle-specific antitumor drug
  • Methotrexate — DRUG
    Antifolate antineoplastic drug
  • Cytarabine — DRUG
    Pyrimidine antimetabolites
  • Prednisone — DRUG
    Glucocorticoids

Study Details

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.

Key Dates

Start date
Apr 2, 2024
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: low-dose chemotherapy, Venetoclax combined with immuno-targeted drugs
    The cycle of induction therapy is administered with immuno-targeted drugs (including Inotuzumab ozogamicin and/or Blinatumomab), a combination of low-dose chemotherapy (including vincristine, cyclophosphamide, dexamethasone, methotrexate and cytarabine) and Venetoclax (VEN).
  • Experimental: low-dose chemotherapy combined with Venetoclax
    The cycle of induction therapy is administered with a combination of low-dose chemotherapy and VEN.

Primary Outcome Measure

MRD-negative complete remission rate measured by flow cytometry. [ Time Frame: After induction (4 week) ]

Central Contacts

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