Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06554626
Phase
PHASE2
Status
Recruiting
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Conditions

  • Precursor B-Cell Lymphoblastic Leukemia

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    Glucocorticoids
  • Blinatumomab — DRUG
    Bi-specific anti CD19/CD3 antibody
  • Venetoclax — DRUG
    BCL-2 inhibotor
  • Inotuzumab ozogamicin — DRUG
    a humanized monoclonal antibody-drug conjugate targeting CD22
  • Methotrexate — DRUG
    antifolate antineoplastic drug
  • Pegaspargase — DRUG
    antitumor drug
  • Cytarabine — DRUG
    Pyrimidine, antimetabolites

Study Details

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Key Dates

Start date
Aug 15, 2024
Status verified
Aug 2024
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Induction Cycle 1 and 2: Venetoclax for 2 weeks,oral; Blinatumomab for 2weeks, iv; Dexamethasone. Consolidation Cycle 3 and 5: Inotuzumab ozogamicin, iv. Cycle 4: Methotrexate, iv. Cycle 6: Venetoclax for 2 weeks,oral; Pegaspargase, im. Complete at least 6 intrathecal injections within 6 cycles.

Primary Outcome Measure

Event free survival(EFS) [ Time Frame: up to 2 years ]

Central Contacts