Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04524455|
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : January 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Blinatumomab Drug: AMG 404 Drug: Dexamethasone Premedication||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||October 2, 2020|
|Actual Primary Completion Date :||January 24, 2023|
|Actual Study Completion Date :||January 24, 2023|
|Experimental: Blinatumomab and AMG 404||
Blinatumomab will be administered as a continuous intravenous infusion (cIV).
Other Name: 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.
- Number of Participants who Experience Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 8 Weeks ]
- Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 51 Weeks ]
- Number of Participants who Experience Serious Treatment-Emergent Adverse Events [ Time Frame: Up to 51 Weeks ]
- Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events [ Time Frame: Up to 51 Weeks ]
- Number of Participants who Experience Adverse Events of Interest (EOI) [ Time Frame: Up to 51 Weeks ]
- Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*) [ Time Frame: Up to 51 Weeks ]
- Complete Remission (CR) Rate [ Time Frame: Up to 51 Weeks ]
- Duration of Complete Remission (CR) [ Time Frame: Up to 51 Weeks ]
- Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*) [ Time Frame: Up to 51 Weeks ]
- Steady State Concentrations (Css) of Blinatumomab [ Time Frame: Up to 35 Weeks ]
- Maximum Observed Concentration (Cmax) of AMG 404 [ Time Frame: Up to 51 Weeks ]
- Time to Maximum Observed Concentration (Tmax) of AMG 404 [ Time Frame: Up to 51 Weeks ]
- Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404 [ Time Frame: Up to 51 Weeks ]
- Number of Participants with Incidences of Anti-Blinatumomab Antibodies [ Time Frame: Up to 35 Weeks ]
- Number of Participants with Incidences of Anti-AMG 404 Antibodies [ Time Frame: Up to 35 Weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524455
|Other Study ID Numbers:||
|First Posted:||August 24, 2020 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.|
|Access Criteria:||Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal