At a glance
ClinicalIndex Comparison Record- ✓Age ≥1 and <22 years at enrollment
- ✓B-ALL or B-lymphoblastic lymphoma with ≥5% bone marrow blasts (M2 or M3)
- ✓CD22 surface expression on leukemic blasts confirmed by flow cytometry
- ✓Second or greater relapse, OR primary refractory with ≥2 prior induction attempts, OR first relapse refractory to ≥1 re-induction, OR any relapse after HSCT (Cohort 1 only)
- ✕Any prior history of sinusoidal obstruction syndrome (SOS)
- ✕Isolated CNS, testicular, or other extramedullary site relapse
- ✕Prior treatment with inotuzumab ozogamicin
- ✕Prior HSCT (Cohort 2 only)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Asparaginase Erwinia chrysanthemi, Biospecimen Collection, and 11 other interventions for Recurrent B Acute Lymphoblastic Leukemia and 3 related conditions. Currently recruiting, targeting 80 participants across 157 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)
See Detailed Description
Interventions
Given Asparaginase Erwinia chrysanthemi
Undergo blood sample collection
Undergo a bone marrow aspiration and biopsy
Given IV
Given IV
Given IV or SC
Undergo imaging
Given IV
Given PO or IV
Undergo lumbar puncture
Given IT
Given IV or IM
Given IV