A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Children's Oncology Group
Summary
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
Description
PRIMARY OBJECTIVE: I. To determine the morphologic response rate (complete response \[CR\] + complete response with incomplete hematologic recovery \[CRi\]) following one cycle of treatment with inotuzumab ozogamicin in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia (B-ALL). (Cohort 1) SECONDARY OBJECTIVES: I. To determine the CR/CRi rate following 2 cycles of inotuzumab ozogamicin therapy. (Cohort 1) II. To determine the safety of single agent inotuzumab ozogamicin administered at the adult recommended phase 2 dose (RP2D) to pediatric patients with relapsed or re…
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be \>= 1 year and \< 22 years of age at the time of enrollment * Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with \>= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease * NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study * Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing \>= 5% blasts by flow cytometry, fluorescence in situ hybridizatio…
Interventions
- DrugAsparaginase Erwinia chrysanthemi
Given Asparaginase Erwinia chrysanthemi
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration and Biopsy
Undergo a bone marrow aspiration and biopsy
- DrugCalaspargase Pegol
Given IV
- DrugCyclophosphamide
Given IV
- DrugCytarabine
Given IV or SC
- ProcedureDiagnostic Imaging Testing
Locations (157)
- Children's Hospital of AlabamaBirmingham, Alabama
- Providence Alaska Medical CenterAnchorage, Alaska
- Banner Children's at DesertMesa, Arizona
- Phoenix Childrens HospitalPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas