Study Information
Summary / Purpose
To determine the morphologic response rate (complete response + complete response with incomplete hematologic recovery) following one cycle of treatment with inotuzumab ozogamicin in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia; To determine the response rate following 2 cycles of inotuzumab ozogamicin therapy
Study Type: Interventional
Accepts Healthy Volunteers: No
Who Can Participate
Eligibility Criteria: - Children and Adults 1-21 years of age
- Must have B-cell acute lymphoblastic leukemia, or previously diagnosed B lymphoblastic lymphoma, with > 5% bone marrow blasts with or without extramedullary disease
- B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma who have M2 morphology must have local confirmatory testing showing > 5% blasts
- Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample
- One of the following: Second or greater relapse: Primary refractory disease with at least 2 prior induction attempts, First relapse refractory to at least one prior re-induction attempt, Any relapse after HSCT
What's Involved
Participation in the study will include: - Induction chemotherapy followed by dasatinib, three cycles of blinatumomab, additional chemotherapy phases including: Interim maintenance, delayed intensification, long-term maintenance (Ph+ B-cell acute lymphoblastic leukemia), or
- Induction chemotherapy followed by imatinib or dasatinib depending on genetic markers, three cycles of blinatumomab and chemotherapy phases (ABL-class Ph-like B-cell acute lymphoblastic leukemia)
Principal Investigator
Additional Information
Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.
