drugset / Trial / NCT04747912
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
Non-randomizedSequentialOpen-labelTreatment
Summary
This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.
Timeline
- Start
- 2021-03-02
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.5 mg/m2 | — |
| Subject | Ponatinib | Small molecule | — | — |
| Subject | dasatinib anhydrous | Small molecule | 140 mg | — |
| Background | Dexamethasone | Small molecule | 10 mg/m2 | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | 15 mg | Intrathecal |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Vincristine | Small molecule | — | — |