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B Acute Lymphoblastic LeukemiaCancerDrugProcedureBiologicalPhase 3

What this study is

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

What's being tested

  • Allopurinol

    Intervention · DRUG

  • Cytarabine

    Intervention · DRUG

    Given IT, IV, SC

  • Daunorubicin Hydrochloride

    Intervention · DRUG

  • Vincristine Sulfate

    Intervention · DRUG

  • Dexamethasone

    Intervention · DRUG

    Given PO or IV

  • Pegylated L-Asparaginase

    Intervention · DRUG

  • Methotrexate

    Intervention · DRUG

    Given IT, IV, PO

  • Bone Marrow Aspiration and Biopsy

    Intervention · PROCEDURE

    Undergo bone marrow aspiration and biopsy

  • Cyclophosphamide

    Intervention · DRUG

  • Mercaptopurine

    Intervention · DRUG

  • Rituximab

    Intervention · BIOLOGICAL

  • Doxorubicin

    Intervention · DRUG

  • Thioguanine

    Intervention · DRUG

  • Inotuzumab Ozogamicin

    Intervention · BIOLOGICAL

  • Laboratory Biomarker Analysis

    Intervention · OTHER

    Correlative studies

All of Allopurinol, Mercaptopurine, Thioguanine

Given PO

All of Daunorubicin Hydrochloride, Vincristine Sulfate, Pegylated L-Asparaginase, Cyclophosphamide, Rituximab, Doxorubicin, Inotuzumab Ozogamicin

Given IV

Study details

Official title
A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL
Sponsor
Alliance for Clinical Trials in Oncology
Conditions
B Acute Lymphoblastic Leukemia
Enrolling
303 people
Starts
2017-09-20
Est. completion
2028-04-01
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗