Non-Hodgkin's LymphomaPhase 1NCT02961881
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
A Phase 1 study testing blinatumomab in people with Non-Hodgkin's Lymphoma, run by Amgen at 17 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 18 Sep 2017to 2 Sep 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
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- 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
- Subjects without standard therapy alternatives, or contraindicated for standard therapy by investigator, or subjects unwilling to receive standard therapy. 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
- 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
- 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:
- peripheral neutrophils >500/µL prior to start of treatment
- hemoglobin ≥8 g/dL
- Platelets greater than or equal to 50,000 mcL
- aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < 5 × upper limit of normal (ULN
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Italy5 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
IRCCS Ospedale San Raffaele
Milan, 20132
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
City of Hope National Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Australia3 sites
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Epworth Healthcare
East Melbourne, Victoria, 3002
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Germany3 sites
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Universitätsklinikum Frankfurt/Main
Frankfurt am Main, 60590
Universitatsklinikum Ulm
Ulm, 89081
France2 sites
Hopital Henri Mondor
Créteil Cedex, 94010
Hopital Saint Louis
Paris, 75475
About this study
Primary Objective:
- To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations
Read more
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
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- blinatumomab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blinatumomabDrug
Blinatumomab used as both continuous IV infusion and subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| blinatumomab | Experimental | Not described Receives: Drug: blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting-Toxicities (DLTs) After SC Administration
The occurrence of any of the following toxicities during the DLT evaluation period was considered a DLT, if judged by the investigator to be related to the administration of blinatumomab:
- Death
- Any toxicity, regardless of grade, that lead to a participant's removal from the study by the investigator and/or sponsor
- Persistent Common Terminology Criteria for Adverse Events (CTCAE) grade >/= 2 non-hematologic adverse events (AEs) that were deemed intolerable by the participant or the treating physician and that did not respond to appropriate medical management within 5 days and lead to treatment discontinuation
- Recurrent grade 2 seizures
- All grade 3 and 4 AEs and laboratory abnormalities, which occurred during the SC administration portion of the treatment period with exceptions noted in protocol section 6.2.1.2.3.
Measured: Day 1 to Day 7 of Week 4
Number of Participants With DLTs CTCAE Grade ≥ 3 After SC Administration
All toxicities were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.
Measured: Day 1 to Day 7 of Week 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) After SC Administration
An AE was defined as any untoward medical occurrence in a clinical study participant. The AE did not necessarily have a causal relationship with study treatment. The definition of AEs included worsening of a pre-existing medical condition.
TEAEs included AEs starting on or after first dose of investigational product and up to the end of study date. All AEs were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.
Measured: Day 1 to end of study (approximately 17 weeks)
Secondary outcomes (14)
Steady State Serum Concentration (Css) of Blinatumomab After cIV Administration
Summarized as the observed concentrations collected after 5 half-lives after the start of the IV infusion of each dose (i.e., 9, 28 and 112 μg/day).
Measured: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6
Systemic Clearance (CL) of Blinatumomab After cIV Administration
Calculated as CL=R0/Css; where R0 is the infusion rate (μg/hr) and Css is the average Css. Both R0 and Css were dose-normalized to 112 μg/day for this calculation.
Measured: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6
Maximum Observed Concentration (Cmax) of Blinatumomab After SC Administration
Measured: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Time at Which Cmax (Tmax) Occurred of Blinatumomab After SC Administration
Measured: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Area Under the Concentration-time Curve (AUC) of Blinatumomab After SC Administration for a Dosing Interval t (AUCt)
Estimated using the linear trapezoidal method; where t is a dosing interval. AUC over the dosing interval, t where t is 12 hours for Cohorts 1 and 2, 24 hours for Cohorts 3 and 4, and 48 hours for Cohort 5.
Measured: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Minimum Observed Concentration (Cmin) of Blinatumomab After SC Administration
Measured: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Apparent Clearance (CL/F) of Blinatumomab After SC Administration
Calculated as CL/F = Dose sc / AUCt-ss (at steady state).
Measured: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Volume of Distribution Based on Terminal Phase (Vz/F) of Blinatumomab After SC Administration
Calculated as Vz/F=CL/F / λz, where λz was the first-order rate constant estimated via linear regression of the terminal log-linear decay phase as determined from the noncompartmental analysis.
Measured: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Terminal Half-life (t1/2,z) of Blinatumomab After SC Administration
Calculated as t1/2,z = ln(2) / λz.
Measured: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Accumulation Ratio of Blinatumomab After SC Administration
Calculated as the ratio of AUCt (last SC dose; Week 4 Day 5) / AUC (first SC dose; Week 4 Day 1).
Measured: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Bioavailability (F) of SC Blinatumomab
Calculated as F = (CL * AUCt-ss) / Dose sc.
Measured: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Maximum Tolerated Dose (MTD) of SC Blinatumomab
The MTD was defined as the highest dose level at which </= 1 of 6 participants experienced a DLT.
Measured: Day 1 to Day 7 of Week 4
Number of Participants With Anti-blinatumomab Antibody Formation After SC Administration
Measured: Predose at the re-start of cIV infusion (Week 5 Day 1)
Overall Response Rate (ORR) After SC Administration
Percentage of participants achieving ORR (complete response [CR] + partial response [PR]) was determined by best overall response using Cheson criteria:
- CR: disappearance of all evidence of disease.
- PR: regression of measurable disease and no new sites.
The 95% confidence interval (CI) was calculated using Clopper-Pearson exact CI. Participants were considered as non-responders if there was no response assessment available.
Measured: Day 1 to end of study (approximately 17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start18 Sep 2017
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961881
- Sponsor's protocol ID
- 20140286
- Other IDs
- 2016-002034-76, 2016
- Status last verified
- May 2023
- First submitted
- 6 Sep 2016
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02961881
- Acronym / sponsor ID
- 20140286
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 2 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blinatumomab | Experimental | Drug: blinatumomab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blinatumomabBlinatumomab used as both continuous IV infusion and subcutaneous injection | Drug | blinatumomab |
Primary outcome
Number of Participants With Dose Limiting-Toxicities (DLTs) After SC Administration
Time frame: Day 1 to Day 7 of Week 4
The occurrence of any of the following toxicities during the DLT evaluation period was considered a DLT, if judged by the investigator to be related to the administration of blinatumomab: * Death * Any toxicity, regardless of grade, that lead to a participant's removal from the study by the investigator and/or sponsor * Persistent Common Terminology Criteria for Adverse Events (CTCAE) grade >/= 2 non-hematologic adverse events (AEs) that were deemed intolerable by the participant or the treating physician and that did not respond to appropriate medical management within 5 days and lead to treatment discontinuation * Recurrent grade 2 seizures * All grade 3 and 4 AEs and laboratory abnormalities, which occurred during the SC administration portion of the treatment period with exceptions noted in protocol section 6.2.1.2.3.
Number of Participants With DLTs CTCAE Grade ≥ 3 After SC Administration
Time frame: Day 1 to Day 7 of Week 4
All toxicities were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) After SC Administration
Time frame: Day 1 to end of study (approximately 17 weeks)
An AE was defined as any untoward medical occurrence in a clinical study participant. The AE did not necessarily have a causal relationship with study treatment. The definition of AEs included worsening of a pre-existing medical condition. TEAEs included AEs starting on or after first dose of investigational product and up to the end of study date. All AEs were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.
14 secondary outcomes
Steady State Serum Concentration (Css) of Blinatumomab After cIV Administration
Time frame: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6
Systemic Clearance (CL) of Blinatumomab After cIV Administration
Time frame: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6
Maximum Observed Concentration (Cmax) of Blinatumomab After SC Administration
Time frame: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Time at Which Cmax (Tmax) Occurred of Blinatumomab After SC Administration
Time frame: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Area Under the Concentration-time Curve (AUC) of Blinatumomab After SC Administration for a Dosing Interval t (AUCt)
Time frame: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Minimum Observed Concentration (Cmin) of Blinatumomab After SC Administration
Time frame: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Apparent Clearance (CL/F) of Blinatumomab After SC Administration
Time frame: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Volume of Distribution Based on Terminal Phase (Vz/F) of Blinatumomab After SC Administration
Time frame: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Terminal Half-life (t1/2,z) of Blinatumomab After SC Administration
Time frame: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Accumulation Ratio of Blinatumomab After SC Administration
Time frame: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Bioavailability (F) of SC Blinatumomab
Time frame: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)
Maximum Tolerated Dose (MTD) of SC Blinatumomab
Time frame: Day 1 to Day 7 of Week 4
Number of Participants With Anti-blinatumomab Antibody Formation After SC Administration
Time frame: Predose at the re-start of cIV infusion (Week 5 Day 1)
Overall Response Rate (ORR) After SC Administration
Time frame: Day 1 to end of study (approximately 17 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing blinatumomab in people with Non-Hodgkin's Lymphoma, run by Amgen at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, United States, Australia, Germany, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting-Toxicities (DLTs) After SC Administration (time frame: Day 1 to Day 7 of Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.