This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. 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.
PRIMARY OBJECTIVES: I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured by the hematologic remission rate (complete remission \[CR\] + CR with incomplete platelet recovery \[CRp\] + CR with incomplete bone marrow recovery \[CRi\]) in patients in first, second or later salvage setting. SECONDARY OBJECTIVES: I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1), progression free survival (PFS), and overall survival (OS). OUTLINE: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Number of Participants to Achieve Complete Remission (CR)
Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.
Time frame: Up to 2 years
Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)
For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.
Time frame: Up to 2 years
Duration of Response
The date of Complete Response to the date of loss of response or last follow-up.
Time frame: Up to 3 years
Progression Free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time frame: Up to 3 years
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up.
Time frame: Up to 3 years
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