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

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin

Trial Details

NCT ID
NCT03959085
Phase
PHASE3
Sponsor
Children's Oncology Group
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Biospecimen Collection
  • Blinatumomab
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Bone Scan
  • Calaspargase Pegol
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Mesa, Arizona, United States|33.42227,-111.82264
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Downey, California, United States|33.94001,-118.13257

Key Eligibility Criteria

  • B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. N…
  • APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy …
  • Patients must be \> 365 days and \< 25 years of age
  • White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):

For full eligibility, visit ClinicalTrials.gov.

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