Study on Treatment for Newly Diagnosed B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT06533748

Provider View

This clinical trial is testing two new therapies, inotuzumab and blinatumomab, for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. The study aims to see if these treatments can improve remission rates and survival compared to previous treatments.

Patient Parameters

Program Overview

This study is exploring the use of two targeted therapies, inotuzumab and blinatumomab, as part of the initial treatment for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. The main goal is to see if these therapies can lead to better remission rates in patients who are at high risk and do not have favorable genetic features. The study will also compare the safety and effectiveness of these therapies to standard treatments and assess the overall survival of patients.

Description

The study involves three main phases of treatment: Induction, Early Post Induction, and Maintenance.

Induction Phase:

  • This phase includes 7 days of initial therapy followed by 5 weeks of treatment. Patients will receive medications like dexamethasone, vincristine, inotuzumab, and blinatumomab. Some patients will also receive dasatinib if they have a specific genetic feature. There will be a break from chemotherapy at the end of this phase unless the disease has not responded well.

Early Post Induction Phase:

  • This phase includes several steps:
    • Consolidation: Patients receive medications like cyclophosphamide, cytarabine, and inotuzumab, with a break at the end.
    • Blinatumomab 1: A four-week treatment with blinatumomab.
    • High-Dose Methotrexate: Given every two weeks for four cycles, along with other medications.
    • Reinduction: Includes medications like dexamethasone, vincristine, and others.
    • Interim: A six-week phase with daily medications and some weekly treatments.
    • Reconsolidation: Similar to Consolidation but with different medications.
    • Blinatumomab 2: Another four-week treatment for certain patients.

Maintenance Phase:

  • This phase follows the Early Post Induction and includes regular treatments over 80 weeks to help keep the cancer in remission.

The total duration of therapy is about 2¼ years, with follow-up recommended until the patient is in remission for 10 years and is at least 18 years old.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the INITIALL study.
  • Age between 1 and 18.99 years.
  • Diagnosed with B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.
  • No prior chemotherapy except as allowed by INITIALL.
  • High-risk patients based on age or white blood cell count, or standard-risk with specific clinical features.
  • Adequate liver and kidney function based on specific medical tests.
  • Eligibility after Induction requires meeting initial criteria and specific treatment responses.

Exclusion Criteria

  • Certain genetic features unless accompanied by high-risk factors.
  • History of significant central nervous system issues or events.
  • Active uncontrolled infection.
  • Current or past autoimmune disease affecting the CNS.
  • History of specific liver conditions.
  • Unstable heart conditions.
  • Inability to provide informed consent.
  • Pregnant or breastfeeding individuals.
  • Unwillingness to use effective contraception during treatment.

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105MemphisTennessee

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