At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults
In Brief
A Phase 3 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, and 19 other interventions for Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative. Active but no longer recruiting, targeting 488 participants across 545 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Undergo allogeneic hematopoietic SCT
Undergo blood sample collection
Given IV
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Given IV
Given IT, IV, or SC
Given IV
Given IV
Given PO
Given IV
Given IV or PO
Undergo lumbar puncture
Given PO
Given PO, IT or IV
Given IM or IV
Given PO
Given IV
Given IV
Given IV
Undergo x-ray imaging