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 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) ...
About
Protocol Description
A 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
The overall goal of this study is to understand whether adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in high-risk B-cell acute lymphoblastic leukemia (HR B-ALL). 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, in order to classify patients into post-consolidation treatment groups.
On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, 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.
COG# AALL1732
Eligibility Criteria
Inclusion Criteria
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
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
Age at diagnosis:
- Patients must be > 365 days and < 25 years of age
Eligibility screening:
- All B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL1732.
- APEC14B1 is not a requirement for B-LLy patients. They may directly enroll on ALL1732.
Exclusion Criteria
- Patients with Down syndrome are not eligible. See AALL1731.
- Patients with acute undifferentiated leukemia (AUL) are not eligible.
- Female patients must not be pregnant.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic, and has over 30 years of clinical experience. He is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, C.C.R.P.
Clinical Research Coordinator II
