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

Sponsor

Amgen (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04524455

Collaborator

(none)

Enrollment

Locations

Arm

32.9

Anticipated Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Blinatumomab Drug: AMG 404 Drug: Dexamethasone Premedication	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Oct 2, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blinatumomab and AMG 404	Drug: Blinatumomab Blinatumomab will be administered as a continuous intravenous infusion (cIV). Other Names: Blincyto Drug: AMG 404 AMG 404 will be administered as an intravenous infusion (IV). Drug: Dexamethasone Premedication Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.

Arm

Intervention/Treatment

Experimental: Blinatumomab and AMG 404

Drug: Blinatumomab

Blinatumomab will be administered as a continuous intravenous infusion (cIV).

Other Names:

Blincyto

Drug: AMG 404

AMG 404 will be administered as an intravenous infusion (IV).

Drug: Dexamethasone Premedication

Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.

Outcome Measures

Primary Outcome Measures

Number of Participants who Experience Dose-Limiting Toxicities (DLTs) [Up to 8 Weeks]
Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) [Up to 51 Weeks]
Number of Participants who Experience Serious Treatment-Emergent Adverse Events [Up to 51 Weeks]
Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events [Up to 51 Weeks]
Number of Participants who Experience Adverse Events of Special Interest (AESI) [Up to 51 Weeks]

Secondary Outcome Measures

Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*) [Up to 51 Weeks]
Complete Remission (CR) Rate [Up to 51 Weeks]
Duration of Complete Remission (CR) [Up to 51 Weeks]
Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*) [Up to 51 Weeks]
Steady State Concentrations (Css) of Blinatumomab [Up to 35 Weeks]
Maximum Observed Concentration (Cmax) of AMG 404 [Up to 51 Weeks]
Time to Maximum Observed Concentration (Tmax) of AMG 404 [Up to 51 Weeks]
Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404 [Up to 51 Weeks]
Number of Participants with Incidences of Anti-Blinatumomab Antibodies [Up to 35 Weeks]
Number of Participants with Incidences of Anti-AMG 404 Antibodies [Up to 35 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of Chicago	Chicago	Illinois	United States	60637
3	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
4	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
5	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
6	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
7	The Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
8	Ordensklinikum Linz Elisabethinen	Linz		Austria	4020
9	Hôpital Saint Louis	Paris		France	75010
10	Centre Hospitalier Lyon Sud	Pierre Benite		France	69645
11	Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main	Frankfurt am Main		Germany	60590
12	Universitätsklinikum Schleswig-Holstein	Kiel		Germany	24105
13	Universitaetsklinikum Regensburg	Regensburg		Germany	93053
14	Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi	Bologna		Italy	40138
15	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia		Italy	25123
16	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
17	Hospital Universitari Germans Trias i Pujol	Badalona	Cataluña	Spain	08916
18	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña	Spain	08036
19	University College London	London		United Kingdom	NW3 2PF