About this trial
This trial looks at how well inotuzumab ozogamicin works with standard chemotherapy for young adults who have just been diagnosed with B acute lymphoblastic leukemia. This combination may help block cancer growth in different ways. The study aims to see if adding this drug can improve treatment results and overall health for patients.
The trial's ID number is NCT03150693. It is a Phase 3 trial, meaning it is checking how well the treatment works and how safe it is. This trial is regulated by the FDA and hopes to include 310 participants.
Who can join
Young adults aged 18 to 39 years can join if they have recently been diagnosed with a specific type of leukemia that is CD-22 positive. Patients with certain genetic markers or other health issues may not be eligible. The trial team will confirm who can join.
Condition
B Acute Lymphoblastic Leukemia
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into two groups. One group will receive standard frontline chemotherapy. The other group will receive the same chemotherapy plus inotuzumab ozogamicin. Everyone will also have tests to check their bone marrow after treatment. Treatments will repeat every 28 days for up to two courses unless there are issues.
Where
This trial is running at 455 locations in the United States. 156 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Augusta University Medical Center
Augusta, Georgia
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan
Benefis Sletten Cancer Institute
Great Falls, Montana
Billings Clinic Cancer Center
Billings, Montana
Bozeman Health Deaconess Hospital
Bozeman, Montana
Bronson Methodist Hospital
Kalamazoo, Michigan
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan
The first 8 of 455 sites are listed here. The registry record has the full list.