What is inotuzumab ozogamicin studying for High-Risk B-cell Acute Lymphoblastic Leukemia?

Inotuzumab ozogamicin is being studied to see if adding it to standard chemo-immunotherapy improves treatment outcomes for High-Risk B-cell Acute Lymphoblastic Leukemia. The study compares standard treatment with and without this drug to understand its impact on survival and side effects.

Who may be eligible for this High-Risk B-cell Acute Lymphoblastic Leukemia clinical trial?

Children and young adults between 1 and 25 years old with newly diagnosed High-Risk B-cell Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, or B-lymphoblastic lymphoma may be eligible. Key factors include no prior chemotherapy except certain steroids, no Down syndrome, and not being pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this High-Risk B-cell Acute Lymphoblastic Leukemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 365Days - 25Years

All Genders

ID03959085

Study of Inotuzumab Ozogamicin with Chemotherapy for Children and Young Adults with High-Risk B-Cell Leukemia, Mixed Phenotype Leukemia, and B-Lymphoblastic Lymphoma

Led by Children's Oncology Group · Updated on 2026-07-16

5951

Participants Needed

231

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating if adding inotuzumab ozogamicin to standard chemo-immunotherapy after initial induction improves outcomes for children and young adults with High-Risk B-cell Acute Lymphoblastic Leukemia B-ALL. The study also includes patients with Mixed Phenotype Acute Leukemia MPAL and B-lymphoblastic lymphoma B-LLy receiving similar therapy. This phase III trial aims to understand whether this addition maintains or improves survival and treatment response while evaluating side effects and quality of life. Participants first complete induction therapy involving multiple chemotherapy drugs and steroids based on age, followed by randomization into one of two groups if they have CD22-positive High-Risk B-ALL. One group receives a modified chemotherapy regimen including inotuzumab ozogamicin, replacing parts of consolidation and delayed intensification phases. The other group receives the full chemo-immunotherapy regimen without inotuzumab. Patients with MPAL and B-LLy receive treatment according to specified arms with similar chemotherapy combinations adjusted for their condition. Treatments involve intravenous, intrathecal, and oral medications, as well as radiation therapy for certain cases. Throughout the study, participants undergo various assessments including blood samples, bone marrow tests, and imaging scans. Side effects and health-related quality of life are monitored using patient-reported outcomes. Adherence to oral chemotherapy and immune system effects are also evaluated. After completing treatment, participants are followed regularly to monitor survival, relapse, and long-term health up to five years. The study also explores social determinants of health and their impact on outcomes.

CONDITIONS

Brief Title

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Who Can Participate

Age: 365Days - 25Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients with B-ALL and MPAL must be enrolled on APEC14B1 and consented to eligibility studies before treatment and enrollment
Patients with B-LLy may enroll directly but should be offered participation in APEC14B1
Age between 1 year and less than 25 years
For B-ALL: initial white blood cell count (WBC) meets age-based criteria or has testicular leukemia, CNS leukemia, or steroid pretreatment
For MPAL: any WBC and must meet criteria if reclassified as B-ALL
Newly diagnosed B-ALL or MPAL with at least 25% blasts in bone marrow or pathologic diagnosis or blood count
Newly diagnosed B-LLy Murphy stages III or IV, or stages I or II with steroid pretreatment
CNS status determined before enrollment
Direct bilirubin less than 2.0 mg/dL
Alanine aminotransferase (ALT) less than or equal to 10 times upper limit of normal (except in Gilbert's syndrome or hepatic involvement)
Signed informed consent and compliance with institutional and regulatory requirements

You will not qualify if you...

Patients with Down syndrome
Prior cytotoxic chemotherapy for current diagnosis except steroid pretreatment or intrathecal cytarabine
More than 72 hours of hydroxyurea within one week before starting protocol therapy
Insufficient diagnostic bone marrow or peripheral blood samples for testing
Patients with acute undifferentiated leukemia
For B-LLy patients: T-lymphoblastic lymphoma, unclassifiable lymphoma, or lack of B-cell and T-cell markers
Known Charcot-Marie-Tooth disease
Known MYC translocation associated with mature (Burkitt) B-cell ALL
Patients requiring radiation at diagnosis
Female patients who are pregnant
Lactating women who plan to breastfeed during and for 2 months after inotuzumab treatment
Sexually active patients not using effective contraception during study and post-treatment period

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Study of Inotuzumab Ozogamicin with Chemotherapy for Children and Young Adults with High-Risk B-Cell Leukemia, Mixed Phenotype Leukemia, and B-Lymphoblastic Lymphoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria