Adding Inotuzumab Ozogamicin to Standard Treatment for High-Risk Blood Cancers

Recruiting · Phase 3 · B Acute Lymphoblastic Leukemia and related conditions · 49 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at adding a medicine called inotuzumab ozogamicin to standard treatment for patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) and other related cancers. The goal is to see if this addition helps improve outcomes for these patients. The study will also include patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy).

The trial's ID number is NCT03959085. It is a Phase 3 study, meaning it aims to learn more about how well the treatment works and how safe it is. This trial is regulated by the FDA, and it hopes to include around 5,951 participants.

Who can join

This trial is open to children and young adults aged 1 to 24 years who have been diagnosed with high-risk B-ALL, MPAL, or B-LLy. They must meet specific health criteria and have consent from their parents or guardians to participate. The trial team will confirm who is eligible before enrollment.

Conditions

B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia

Age group

Child, Adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly assigned to different groups. Some will receive standard treatment with inotuzumab ozogamicin, while others will receive standard treatment without it. Everyone will also receive other treatments like chemotherapy, and some will undergo various tests to monitor their health.