Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 99
Clinical summary
Summary
This trial has one experimental arm. All participants will receive Blinatumomab (administered as a continuous intravenous infusion) and AMG 404 (administered as an intravenous infusion). Participants will also be administered Dexamethasone (orally or intravenously) prior to blinatumomab treatment as needed.
Conditions
This trial is treating people with acute lymphoblastic leukaemia
Eligibility
Inclusion
- 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
- Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
- Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AMGEN
Scientific Title
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)
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