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

Summary

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen 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. The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-consolidation treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance 1, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. 

Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to females, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell lymphoblastic leukemia (B LLy) or mixed phenotype acute leukemia (MPAL) when treated with B-ALL chemotherapy.

To be included in AALL1732, participants must be / have

Diagnosis: 

• Patient has newly diagnosed B-ALL or MPAL with > 25% blasts on a BM aspirate
• Patient has newly diagnosed B-LLy Murphy stages III or IV
• Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment
• Patients must be > 365 days and < 25 years of age

White blood cell (WBC) count criteria:

• 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:
    • Testicular leukemia
    • CNS leukemia (CNS3)
    • Steroid pretreatment           
• WBC criteria for patients with MPAL

  • Age 1-24.99 years: any WBC

     

To be included in AALL1732, participants must not be / have

• Patients with Down syndrome are not eligible. See AALL1731.
• Patients with acute undifferentiated leukemia (AUL) are not eligible.

• Female patients must not be pregnant.

   

Keywords

Chemotherapy; Leukemia