Phase 3Active, not recruiting
Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults
- Sponsor
- National Cancer Institute (NCI) (NIH)
- Enrolment
- 488 enrolled
- Conditions
- Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
- Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation; Biospecimen Collection; Blinatumomab; Bone Marrow Aspiration; Bone Marrow Biopsy; Cyclophosphamide; Cytarabine; Daunorubicin; Daunorubicin Hydrochloride; Dexamethasone; Etoposide; Leucovorin Calcium
- Ages
- adults, older adults
- Registry
- NCT02003222
From the registry
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Primary outcomes
- Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy