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A Study of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Acute Lymphoblastic Leukemia (ALL)

Trial Status: Active

The primary objectives of this study are to evaluate the safety and tolerability of blinatumomab in combination with AMG 404 in adults with acute lymphoblastic leukemia (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.

Inclusion Criteria

  • Age ≥ 18 years at enrollment.
  • Greater than or equal to 5% blasts in the bone marrow.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
  • Negative pregnancy test in women of childbearing potential.

Exclusion Criteria

  • Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 21 days prior to study Day 1.
  • Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Amgen, Inc.

  • Primary ID 20190177
  • Secondary IDs NCI-2020-07630
  • Clinicaltrials.gov ID NCT04524455