Clinical Trial: NCT04524455 - My Cancer Genome

NCT04524455

Description:

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.

Related Conditions:

Acute Lymphoblastic Leukemia

Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04524455

Trial Eligibility

Document

Title

Brief Title: Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Official 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)

Clinical Trial IDs

ORG STUDY ID: 20190177
NCT ID: NCT04524455

Conditions

Acute Lymphoblastic Leukemia

Interventions

Drug	Synonyms	Arms
Blinatumomab	Blincyto	Blinatumomab and AMG 404
AMG 404		Blinatumomab and AMG 404
Dexamethasone Premedication		Blinatumomab and AMG 404

Purpose

Trial Arms

Name	Type	Description	Interventions
Blinatumomab and AMG 404	Experimental		Blinatumomab AMG 404 Dexamethasone Premedication

Eligibility Criteria

        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 14 days prior to study Day 1.

          -  Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product
             formulation.

Maximum Eligible Age:	99 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Time Frame:	Up to 8 Weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*)
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Complete Remission (CR) Rate
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Duration of Complete Remission (CR)
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*)
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Steady State Concentrations (Css) of Blinatumomab
Time Frame:	Up to 35 Weeks
Safety Issue:
Description:

Measure:	Maximum Observed Concentration (Cmax) of AMG 404
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Time to Maximum Observed Concentration (Tmax) of AMG 404
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404
Time Frame:	Up to 51 Weeks
Safety Issue:
Description:

Measure:	Number of Participants with Incidences of Anti-Blinatumomab Antibodies
Time Frame:	Up to 35 Weeks
Safety Issue:
Description:

Measure:	Number of Participants with Incidences of Anti-AMG 404 Antibodies
Time Frame:	Up to 35 Weeks
Safety Issue:
Description:

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Amgen

Trial Keywords

Blinatumomab
AMG 404
Leukemia

Last Updated

August 12, 2021

Clinical Trials /

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL