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

  • STATUS
    Recruiting
  • End date
    Sep 4, 2021
  • participants needed
    65
  • sponsor
    Amgen
Updated on 9 April 2021
ct scan
chronic lymphocytic leukemia
hodgkin's disease
monoclonal antibodies
measurable disease
follicular lymphoma
mantle cell lymphoma
marginal zone lymphoma
anti-cd20 monoclonal antibody
indolent lymphoma

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

Details
Condition Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment Blinatumomab
Clinical Study IdentifierNCT02961881
SponsorAmgen
Last Modified on9 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Non-Hodgkin's Lymphoma or Lymphoma?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or non-hodgkin's lymphoma (nhl)?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or non-hodgkin's lymphoma (nhl)?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or non-hodgkin's lymphoma (nhl)?
Do you have any of these conditions: Lymphoma or non-hodgkin's lymphoma (nhl) or Non-Hodgkin's Lymphoma?
Do you have any of these conditions: non-hodgkin's lymphoma (nhl) or Lymphoma or Non-Hodgkin's Lymphoma?
Do you have any of these conditions: Non-Hodgkin's Lymphoma or non-hodgkin's lymphoma (nhl) or Lymphoma?
Do you have any of these conditions: non-hodgkin's lymphoma (nhl) or Lymphoma or Non-Hodgkin's Lymphoma?
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
Follicular Lymphoma I, II, IIIA
therapy or have relapsed disease
Lymphoplasmocytic lymphoma
Marginal zone lymphoma (extranodal, nodal or splenic). Subjects with gastric mucosa-
Small lymphocytic lymphoma
associated lymphoid tissue must have progressed after Helicobacter pylori therapy and
radiation. Subjects with splenic marginal zone lymphoma must have prior splenectomy
Primary refractory (at least 1 prior line of therapy)
Mantle cell lymphoma ([MCL] with the exception of aggressive MCL, defined as Ki67 > 30%
Relapsed within 1 year of first response
or blastoid histology)
Responded to initial therapy for 1 year and relapsed after 2 or more lines of therapy, including an anti-CD20 monoclonal antibody
Subjects without standard therapy alternatives, or contraindicated for
standard therapy by investigator, or subjects unwilling to receive standard
Life expectancy greater than or equal to 3 months as determined by treating physician
therapy. Disease status must be 1 of the following
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)
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
Creatinine clearance greater than or equal to 50 mL/min (Cockcroft-Gault)
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
peripheral neutrophils >500/L prior to start of treatment
hemoglobin 8 g/dL
aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < 5 upper limit of normal (ULN

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
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