At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 1 clinical trial evaluating Blinatumomab, AMG 404, and 1 other intervention for Acute Lymphoblastic Leukemia. Completed, enrolled 17 participants across 19 sites in 9 countries.
Detailed Summary
The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.
Study Details
Timeline
Interventions
Blinatumomab will be administered as a continuous intravenous infusion (cIV).
AMG 404 will be administered as an intravenous infusion (IV).
Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.