Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Summary
This phase Ib/II trial studies the effects of tagraxofusp and low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp with chemotherapy may help control CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.
Timeline
- Start
- 2022-02-17
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tagraxofusp | Protein / enzyme biologic | — | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Dexamethasone | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |