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A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

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: NCT02961881
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

Primary Objective:

• To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations

Secondary Objectives:

  • To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations
  • To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously
  • To determine the incidence of anti-blinatumomab antibody formation following SC administration
  • To evaluate efficacy response following treatment with SC blinatumomab administration

Exploratory Objective:

  • To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration
  • To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: blinatumomab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 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 and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : May 6, 2022
Estimated Study Completion Date : May 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: blinatumomab Drug: blinatumomab
Drug used as a treatment for relapsed/refractory B-cell precursor ALL




Primary Outcome Measures :
  1. Subject grade of dose limiting toxicities (DLTs) [ Time Frame: 37 months ]
    Subject grade of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of blinatumomab.

  2. Incidence of dose limiting toxicities (DLTs) [ Time Frame: 37 months ]
  3. Severity of dose limiting toxicities (DLTs) [ Time Frame: 37 months ]
    Severity of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of blinatumomab.

  4. Adverse Events [ Time Frame: 37 months ]

Secondary Outcome Measures :
  1. Blinatumomab PK parameters (clearance of blinatumomab) under cIV [ Time Frame: 37 months ]
  2. Blinatumomab PK parameters (volume of distribution of blinatumomab) under cIV [ Time Frame: 37 months ]
  3. Blinatumomab PK parameters (clearance of blinatumomab) under SC administrations [ Time Frame: 37 months ]
  4. Blinatumomab PK parameters (volume of distribution of blinatumomab) under SC administrations [ Time Frame: 37 months ]
  5. Maximum Tolerated Dose [ Time Frame: 37 months ]
  6. Incidence of anti-blinatumomab antibodies [ Time Frame: 37 months ]
  7. Overall Response Rate (ORR) [ Time Frame: 37 months ]
  8. Complete Response (CR) [ Time Frame: 37 months ]
  9. Partial Response (PR) as determined by best overall response (ORR) using Cheson criteria [ Time Frame: 37 months ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or subject's legally acceptable representative has provided informed consent.
  • Age greater than or equal to 18 years old at the time of informed consent
  • Subjects must have a histologically determined B cell NHL subtype as defined in the bullets below. In addition, they must have disease that is primary refractory after initial therapy or have relapsed disease.
  • Follicular Lymphoma I, II, IIIA
  • Marginal zone lymphoma (extranodal, nodal or splenic). Subjects with gastric mucosa-associated lymphoid tissue must have progressed after Helicobacter pylori therapy and radiation. Subjects with splenic marginal zone lymphoma must have prior splenectomy.
  • Lymphoplasmocytic lymphoma
  • Mantle cell lymphoma ([MCL] with the exception of aggressive MCL, defined as Ki67 > 30%, or blastoid histology)
  • Small lymphocytic lymphoma
  • Disease status must be 1 of the following:
  • Primary refractory (at least 1 prior line of therapy)
  • Relapsed within 1 year of first response
  • Responded to initial therapy for ≥ 1 year and relapsed after 2 or more lines of therapy, including an anti-CD20 monoclonal antibody
  • At least 1 prior line of therapy if primary refractory or relapsed within 1 year. Subjects who respond to initial therapy for greater than or equal to 1 year must have had at least 2 prior lines of therapy including an anti-CD20 monoclonal antibody.
  • Measurable disease that has not been previously irradiated on positron emission tomography-computed tomography (PET-CT), or computed tomography (CT), of at least 1.5 cm within the last 21 days before the start of IP treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Appendix D).
  • Life expectancy greater than or equal to 3 months as determined by treating physician.
  • Subjects must have adequate organ and marrow at screening as defined below:

    • Platelets greater than or equal to 50,000 mcL
    • Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
    • Creatinine clearance greater than or equal to 50 mL/min (Cockcroft-Gault)

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days between ending treatment on another investigational device or drug study(ies) and start of IP treatment. Other investigational procedures while participating in this study are excluded.
  • Known hypersensitivity to immunoglobulins or any other component of the study drug
  • Subject likely to not be available to complete all protocol required study visits or procedures to the best of the subject and investigator's knowledge
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation procedures or completion.
  • Subjects who have had treatments with anti-cancer agents including rituximab or obinutuzumab and/or other monoclonal antibody or radioimmunotherapy within 6 weeks before the starting IP treatment.
  • Autologous stem cell transplantation within 12 weeks before the starting IP treatment or past history of allogeneic stem cell transplantation.
  • Subjects who have received anti-CD 19 targeted therapies, chimeric antigen receptor T-cell or other cellular therapies for the treatment of their lymphoma .
  • Subjects with suspected or known brain metastases should be excluded from this clinical study because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
  • History of or current relevant central nervous system pathology such as epilepsy, recurrent seizures, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome or psychosis.
  • History of malignancy other than their lymphoma with the exception of:

    • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated cervical carcinoma in situ without evidence of disease.
    • Adequately treated breast ductal carcinoma in situ without evidence of disease
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or uncontrolled systemic fungal bacteria, viral, or other infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • A female who is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 48 hours (Period 1) or 96 hours (Period 2), respectively, after the last dose of blinatumomab (Female subjects of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test).
  • A female of childbearing potential unwilling to use highly effective method of contraception during treatment and for an additional 48 hours (Period 1) or 96 hours (Period 2), respectively, after the last dose of blinatumomab.

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): NCT02961881


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

Locations
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United States, California
Research Site Completed
Duarte, California, United States, 91010
United States, New Jersey
Research Site Completed
Hackensack, New Jersey, United States, 07601
Australia, New South Wales
Research Site Recruiting
Concord, New South Wales, Australia, 2139
Australia, Victoria
Research Site Recruiting
East Melbourne, Victoria, Australia, 3002
Research Site Recruiting
Fitzroy, Victoria, Australia, 3065
France
Research Site Recruiting
Créteil Cedex, France, 94010
Research Site Recruiting
Paris Cedex 10, France, 75475
Germany
Research Site Recruiting
Dresden, Germany, 01307
Research Site Completed
Frankfurt am Main, Germany, 60590
Research Site Recruiting
Ulm, Germany, 89081
Italy
Research Site Recruiting
Bergamo, Italy, 24127
Research Site Completed
Bologna, Italy, 40138
Research Site Recruiting
Brescia, Italy, 25123
Research Site Recruiting
Milano, Italy, 20132
Research Site Completed
Rozzano MI, Italy, 20089
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: NCT02961881    
Other Study ID Numbers: 20140286
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link 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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blinatumomab
Antineoplastic Agents