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

ID#: NCT04524455

Age: 18 - 99 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: October 02, 2020

End Date: January 31, 2023

Contact Information:
Amgen Call Center
866-572-6436
Summary: 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.
Eligibility: 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.