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Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, 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

Objective

To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicin to modified Berlin-Frankfurt-Münster (mBFM) chemotherapy will improve 5-year disease-free survival (DFS) in children and young adults with High-Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL).

Protocol #

AALL1732

Trial Phase:

Phase III

Principal Investigator:

Griffin, Jordyn

Cancer Type
  • Leukemia
  • other
  • Lymphoid Leukemia
  • Myeloid and Monocytic Leukemia
  • Non-Hodgkin's Lymphoma
Study Site
  • Virginia Commonwealth University

Inclusion Criteria:
- Patients must be > 365 days and < 25 years of age
- White Blood Cell Count (WBC) Criteria:
- White Blood Cell Count (WBC) Criteria for patients with B-ALL
Age 1-9.99 years: WBC >/= 50,000/µL
Age 10-24.99 years: Any WBC
Age 1-9.99 years: WBC < 50,000/µL with:
o Testicular leukemia
o CNS leukemia (CNS3)
o Steroid pretreatment
- White Blood Cell Count (WBC) Criteria for patients with MPAL
Age 1-24.99 years: any WBC
- Patient has newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with >25% blasts on a bone marrow (BM) aspirate
-
- OR Patient has newly diagnosed B-LLy Murphy Stages III or IV



Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Both
  • Protocol Type Treatment
  • Research Study Team Lindsey Gwaltney, MS, RN
    Phone: +1 804-628-2112
    Email Study Contact

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