Inotuzumab + Blinatumomab for Acute Lymphoblastic Leukemia

This trial tests two treatments, inotuzumab ozogamicin and blinatumomab, to evaluate their effectiveness against CD22-positive B-lineage acute lymphoblastic leukemia (ALL). These drugs are a type of immunotherapy, designed to help the immune system fight cancer cells. Suitable candidates for this trial include individuals with newly diagnosed ALL, those whose ALL has returned after treatment, or those who haven't responded to other treatments. Participants should have a specific leukemia profile, such as being Philadelphia chromosome/BCR-ABL1-negative, and show no active signs of cancer in the central nervous system. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial protocol does not specify if you need to stop taking your current medications. However, certain prior treatments for leukemia must be completed at least 14 days before starting the trial, with some exceptions like intrathecal chemotherapy and corticosteroids, which must be completed 24 hours before starting the trial.

Research has shown that the combination of inotuzumab ozogamicin and blinatumomab has been studied for safety in people with acute lymphoblastic leukemia. These studies indicate that this treatment is generally well-tolerated. Some patients have experienced common side effects, such as low blood cell counts, which can increase the risk of infections, and changes in liver function.

Inotuzumab ozogamicin has been used in other leukemia treatments, and its safety is well-known. Blinatumomab is also approved for treating certain types of leukemia and has a recognized safety record. Together, these drugs aim to help the immune system fight cancer, and their combination has been tested in trials to ensure safety.

Researchers are excited about using inotuzumab ozogamicin and blinatumomab for treating acute lymphoblastic leukemia (ALL) because they offer a novel approach compared to traditional chemotherapy. Inotuzumab ozogamicin is an antibody-drug conjugate that specifically targets CD22-positive cancer cells, delivering a potent toxin directly to the leukemia cells, which could minimize damage to healthy cells. Blinatumomab is a bispecific T-cell engager that connects T-cells to cancer cells, helping the immune system to attack the leukemia more effectively. This combination could lead to more targeted and potentially more effective treatment, with fewer side effects than the standard chemotherapy options.

Research has shown that two treatments, inotuzumab ozogamicin and blinatumomab, hold promise for treating acute lymphoblastic leukemia (ALL). This trial will administer a combination of both inotuzumab ozogamicin and blinatumomab to participants. Inotuzumab ozogamicin proves effective as an initial treatment, while blinatumomab achieves similar success in patients whose ALL has returned or not responded to other treatments. These treatments, known as monoclonal antibodies, help the immune system identify and attack leukemia cells. Studies suggest these drugs can yield better results than standard treatments. Overall, evidence supports their use in managing CD22-positive B-lineage ALL.⁴⁶⁷⁸⁹