NCT03913559 - Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 14, 2019

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2031

Conditions

Acute Lymphoblastic Leukemia

Interventions

DRUG

Inotuzumab ozogamicin

dose: 0.5 mg/m2 IV over 60 minutes, days: 1, 8 and 15 every 4 weeks (28 days per cycle) for up to 6 cycles.

DRUG

Methotrexate

Intrathecal (IT) therapy

DRUG

Hydrocortisone

Intrathecal (IT) therapy

DRUG

Cytarabine

Intrathecal (IT) therapy

DRUG

Diphenhydramine

1 mg/kg (max 50 mg) IV

DRUG

Acetaminophen

10 mg/kg (max 650 mg) PO x 1

DRUG

Methylprednisolone

1 mg/kg IV x 1

Trial Locations (2)

RECRUITING

St. Jude Children's Research Hospital, Memphis

RECRUITING

Rady Children's Hospital San Diego, San Diego