OncoMatch/Clinical Trials/NCT02981628
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
Is NCT02981628 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for recurrent b acute lymphoblastic leukemia.
Treatment: Asparaginase Erwinia chrysanthemi · Calaspargase Pegol · Cyclophosphamide · Cytarabine · Inotuzumab Ozogamicin · Leucovorin Calcium · Methotrexate · Pegaspargase · Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD22 surface expression (positive)
Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: inotuzumab ozogamicin
Patients who have been previously treated with inotuzumab ozogamicin
Cannot have received: stem cell transplant
Exception: Cohort 1 only
Patients who have previously received HSCT (Cohort 2 only)
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender thresholds
Liver function
Direct bilirubin =< 1.5 x ULN for age; ALT =< 5 x ULN for age (ULN for ALT 45 U/L)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or A serum creatinine based on age/gender as follows: ... Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Providence Alaska Medical Center · Anchorage, Alaska
- Banner Children's at Desert · Mesa, Arizona
- Phoenix Childrens Hospital · Phoenix, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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