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Cancer Clinical Trials - COG-AALL1732


Protocol Summary

    Protocol No
    COG-AALL1732
    Principal Investigator
    Michael Burke
    Phase
    III
    Title
    A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
    Associated Disease(s)
    Acute Lymphoblastic Leukemia (ALL)
    Other Leukemia
    Description (Summary)
    For B-ALL: We wish to improve outcomes for patients with NCI HR B-ALL and patients with NCI SR B-ALL and high risk features (leukemia that has spread to the spinal fluid or testes, or received steroid treatment before being diagnosed with leukemia) For B-LLy Historically, B-LLy was treated similar to B-cell acute lymphoblastic leukemia (B-ALL) with good results. B-ALL is a kind of cancer that occurs in the bone marrow, and is more common than B-LLy. Having B-ALL that is “high-risk” (HR) means that there is a higher chance of relapse, similar to having B-LLy that is disseminated. For this reason, HR B-ALL patients receive stronger therapy. Since the last time we have studied the treatment for B-LLy, multiple improvements in treatment for HR B-ALL have been made. We want to see if using the current standard of care (treatment and tests that are currently used for patients who are not participating in research studies) therapy that is currently used for HR B-ALL will also result in good outcomes for patients with disseminated B-LLy. In the past, treatment included a drug called methotrexate, given by mouth during Interim Maintenance. Studies in HR B-ALL have shown that methotrexate given into a vein during Interim Maintenance improved outcomes compared to methotrexate given by mouth. Also, in the past, the medicine called L-asparaginase was given in multiple shots injected into the leg muscle during Induction and Delayed Intensification. L-asparaginase is not widely available anymore. There is a newer form of asparaginase (pegaspargase) where a single dose is used instead of multiple shots injected into the leg muscle. These treatments are now standard of care for HR B-ALL. This clinical trial will test whether these improvements in treatment for HR B-ALL will also improve outcomes in patients with disseminated B-LLy. Compared to previous therapy used in patients with disseminated B-LLy, this study uses more intensive treatment in the Consolidation and Interim Maintenance phases. Specifically, Consolidation in this protocol is two months long instead of one month, with the first 4 weeks repeating itself. This protocol has two Interim Maintenance phases (I and II) instead of one. Both phases use more intensive methotrexate treatment than previously. The change of L-asparaginase to pegaspargase does not change intensity of therapy. The use of the more intensive therapy to treat B-LLy is experimental. For MPAL: We wish to improve the outcomes for patients with MPAL. The treatment used for subjects (people who agree to take part in this study) on this study is the same that is currently used at COG centers for children, adolescents, and young adults with HR B-ALL. To date, there has not been a uniform approach to the treatment of MPAL. Recent studies suggest that many patients with MPAL have good outcomes with HR B-ALL therapy alone and may not require more intense chemotherapy (such as that used for AML) or HSCT. The treatment on this study is experimental because this is the first time that a relatively large group of subjects with MPAL will be treated and studied using HR B-ALL therapy.
    Participating Institutions
    Childrens Hospital of Wisconsin
    ClinicalTrials.gov
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Michael Burke, MD

"The steady improvement in survival for children with cancer is a direct result of their enrollment onto clinical trials; without which we would remain decades behind in terms of scientific advances in pediatric cancer." ~Michael J. Burke, MD