At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
In Brief
A Phase 3 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase, and 17 other interventions for Recurrent B Acute Lymphoblastic Leukemia. Active but no longer recruiting, targeting 669 participants across 186 sites in 5 countries.
Signals
Detailed Summary
This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.
Study Details
Timeline
Arms & Interventions
Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT. Closed effective September 18, 2019.
Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.
Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.
Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance.
Interventions
Undergo allogeneic HSCT
Given IM or IV
Given IV
Given IV
Given IT and IV or SC
Given PO or IV
Given IV
Given IV or PO
Given PO
Given IT, IV, and PO
Given IV
Given IV
Given IV
Correlative studies
Undergo cranial radiation therapy
Given IT
Given PO
Given IV
Given IV