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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT02981628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior inotuzumab ozogamicin, stem cell transplant disqualifies patients from enrollment.
Does this trial require CD22?
Yes, CD22 surface expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify