Study on Inotuzumab Ozogamicin and Post-Induction Chemotherapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-Lymphoblastic Lymphoma

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03959085

Provider View

This clinical trial is exploring whether adding inotuzumab ozogamicin to standard chemotherapy can improve treatment outcomes for patients with high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL). It also examines the effects of standard chemotherapy on patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy).

Patient Parameters

Program Overview

The study aims to find out if adding a drug called inotuzumab ozogamicin to the usual chemotherapy can help patients with high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) have better outcomes. Inotuzumab ozogamicin is a special type of treatment that targets cancer cells directly. The trial also looks at how patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy) respond to standard chemotherapy. The study will track the progress of patients and see if the new treatment plan is more effective than the current standard.

Description

The main goal of this study is to compare the 5-year disease-free survival (DFS) of children and young adults with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who receive a modified chemotherapy treatment with or without the addition of inotuzumab ozogamicin. The study will also look at the safety and side effects of adding inotuzumab ozogamicin to the treatment plan.

Secondary goals include understanding how well patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy) respond to the treatment. The study will also explore how well patients stick to their oral chemotherapy regimen and the impact of different interventions to improve adherence.

All patients will start with the same initial treatment phase, which includes induction and consolidation therapy. After this, patients will be divided into different groups based on their specific type of leukemia and their response to the initial treatment. Some patients will receive additional cycles of chemotherapy, and some will be randomly chosen to receive inotuzumab ozogamicin. The study will also investigate whether treating both boys and girls with the same duration of chemotherapy affects outcomes, as boys have traditionally received an extra year of treatment compared to girls.

The study will follow patients for several years to monitor their health and the effectiveness of the treatment. Patients will undergo various tests, including blood samples and bone marrow biopsies, to track their progress.

Eligibility Criteria

Inclusion Criteria

  • Patients with B-ALL and MPAL must be enrolled in a specific study (APEC14B1) and consent to eligibility studies before starting treatment.
  • Patients must be between 1 and 24 years old.
  • Patients with B-ALL must meet specific white blood cell count criteria based on age.
  • Patients with MPAL must meet specific criteria for white blood cell count.
  • Patients must have a new diagnosis of B-ALL or MPAL with a certain percentage of cancer cells in the bone marrow.
  • Patients with B-LLy must have a new diagnosis of certain stages of the disease.
  • Central nervous system status must be determined before starting treatment.
  • All patients and their guardians must sign a consent form.

Exclusion Criteria

  • Patients with Down syndrome are not eligible.
  • Patients must not have received prior chemotherapy for the current diagnosis, except for certain pre-treatments.
  • Patients who have received more than 72 hours of hydroxyurea before starting treatment are not eligible.
  • Patients with acute undifferentiated leukemia are not eligible.
  • Patients with certain types of lymphoma or specific genetic markers are not eligible.
  • Pregnant or breastfeeding women are not eligible.
  • Sexually active patients must agree to use effective contraception during the study.

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