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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524455
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 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 : October 2, 2020
Estimated Primary Completion Date : February 21, 2023
Estimated Study Completion Date : February 21, 2023


Arm Intervention/treatment
Experimental: Blinatumomab and AMG 404 Drug: Blinatumomab
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.




Primary Outcome Measures :
  1. Number of Participants who Experience Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 8 Weeks ]
  2. Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 51 Weeks ]
  3. Number of Participants who Experience Serious Treatment-Emergent Adverse Events [ Time Frame: Up to 51 Weeks ]
  4. Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events [ Time Frame: Up to 51 Weeks ]
  5. Number of Participants who Experience Adverse Events of Special Interest (AESI) [ Time Frame: Up to 51 Weeks ]

Secondary Outcome Measures :
  1. Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*) [ Time Frame: Up to 51 Weeks ]
  2. Complete Remission (CR) Rate [ Time Frame: Up to 51 Weeks ]
  3. Duration of Complete Remission (CR) [ Time Frame: Up to 51 Weeks ]
  4. Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*) [ Time Frame: Up to 51 Weeks ]
  5. Steady State Concentrations (Css) of Blinatumomab [ Time Frame: Up to 35 Weeks ]
  6. Maximum Observed Concentration (Cmax) of AMG 404 [ Time Frame: Up to 51 Weeks ]
  7. Time to Maximum Observed Concentration (Tmax) of AMG 404 [ Time Frame: Up to 51 Weeks ]
  8. Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404 [ Time Frame: Up to 51 Weeks ]
  9. Number of Participants with Incidences of Anti-Blinatumomab Antibodies [ Time Frame: Up to 35 Weeks ]
  10. Number of Participants with Incidences of Anti-AMG 404 Antibodies [ Time Frame: Up to 35 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04524455    
Other Study ID Numbers: 20190177
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
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.
Supporting Materials: Study Protocol
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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Blinatumomab
AMG 404
Leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Blinatumomab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents