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Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Primary Purpose

B-Cell Non Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Non Hodgkin Lymphoma focused on measuring Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma, Blinatumomab, Leukemia, Standard of Care, SOC, Cancer, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:

    • Lymphoblastic lymphoma
    • Burkitt lymphoma
    • Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.
  • Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
  • Biopsy proven confirmation of relapsed disease.
  • Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
  • Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
  • Eastern Cooperative Oncology Group performance status less than or equal to 2
  • Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT)
  • Laboratory parameters:

Hematology:

  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Platelets ≥ 75 x 10^9/L

Chemistry:

  • Creatinine clearance ≥ 50 mL/min
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
  • Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)

Exclusion Criteria:

  • CMR following S1 chemotherapy
  • Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
  • Prior anti-CD19-directed therapies
  • Prior HDT with autologous HSCT
  • Prior allogeneic HSCT
  • Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  • Evidence of CNS involvement by NHL
  • Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive)

  • History of malignancy other than B-NHL within the past 3 years with the exception of:

    • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment
    • Adequately treated non-melanoma skin cancer or lentigo maligna
    • Adequately treated cervical carcinoma in situ
    • Adequately treated breast ductal carcinoma in situ
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer
    • Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
  • Known sensitivity to immunoglobulins or any of the components to be administered during dosing.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab

Arm Description

Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle.

Outcomes

Primary Outcome Measures

Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

Secondary Outcome Measures

Phase 2: Overall Survival (OS)
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using Kaplan-Meier estimates.
Phase 2: Objective Response Rate (ORR)
ORR is inclusive of all participants who achieved CMR or those who achieved partial metabolic response (PMR), as determined by central radiographic assessment of PET/CT scans using the Lugano Classification.
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from start of treatment with blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. PFS was estimated using Kaplan-Meier method.
Phase 2: Duration of Response (DOR)
DOR was calculated only for participants who achieve a response (CMR or PMR). The duration was calculated from the date a response, CMR or PMR, was first achieved until the earliest date of a disease assessment indicating disease progression or death, whichever occured first. DOR was estimated using Kaplan-Meier method.
Phase 2: Percentage of Participants Who Experienced Successful Mobilization
Successful mobilization rate was defined as the percentage of participants who initiated mobilization while in remission and without any other anti-tumor therapy where the mobilization procedure had an outcome of 'Successful'. Successful mobilization was dictated by institutional standards and defined when the target cell dose was no less than 2 x 10^6 CD34+ cells/kg.
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
The percentage of responders per investigator's review (participants who achieved either CMR or PMR during the treatment) who have undergone allogeneic (allo) HSCT or autologous (auto) HSCT while in remission and without any other anti-cancer treatment.
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events
Non-relapse mortality rate at 100 days after HSCT was calculated as the percentage of participants who died not due to relapse. Only participants who achieved a response per investigator's review and underwent autoHSCT are included.
Phase 2: Blinatumomab Steady State Concentrations (Css)
Pharmacokinetic (PK) parameters were estimated by non compartmental analysis. The Css of blinatumomab was summarized as the observed concentrations collected after at least 24 hours after the start of continuous IV infusion or start of dose step, where appropriate.
Phase 2: Blinatumomab Clearance (CL)
Serum blinatumomab CL was calculated as CL=R0/Css,DN; where R0 is the infusion rate (μg/hr) and Css,DN is the dose normalized average Css. For the CL calculation, the Css,DN was normalized to the 112 μg/day dose in which the value of dose in units of μg/hr was used for the infusion rate.
Phase 2: Half-life of Blinatumomab
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Treatment-emergent adverse events were events with an onset after the administration of the first dose of blinatumomab. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Phase 3: Objective Response Rate (ORR)
Phase 3: Progression Free Survival (PFS)
Phase 3: Duration of Response (DOR)
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Phase 3: Blinatumomab Clearance (CL)
Phase 3: Half-life of Blinatumomab

Full Information

First Posted
August 30, 2016
Last Updated
December 18, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02910063
Brief Title
Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL
Official Title
A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy. In March 2019, decision made to not proceed with phase 3.
Detailed Description
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy. In March 2019, decision made to not proceed with phase 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Non Hodgkin Lymphoma
Keywords
Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma, Blinatumomab, Leukemia, Standard of Care, SOC, Cancer, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinatumomab
Arm Type
Experimental
Arm Description
Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG 103, Blincyto
Intervention Description
Blinatumomab monotherapy
Primary Outcome Measure Information:
Title
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)
Description
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Time Frame
Up to 12 weeks after first dose of blinatumomab
Title
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)
Description
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Time Frame
Up to 12 weeks after first dose of study treatment
Secondary Outcome Measure Information:
Title
Phase 2: Overall Survival (OS)
Description
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using Kaplan-Meier estimates.
Time Frame
From randomization until the end of study, up to 30 months
Title
Phase 2: Objective Response Rate (ORR)
Description
ORR is inclusive of all participants who achieved CMR or those who achieved partial metabolic response (PMR), as determined by central radiographic assessment of PET/CT scans using the Lugano Classification.
Time Frame
Up to 12 weeks after first dose of blinatumomab
Title
Phase 2: Progression Free Survival (PFS)
Description
PFS was defined as the time from start of treatment with blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. PFS was estimated using Kaplan-Meier method.
Time Frame
From first dose of blinatumomab until the end of study, up to 30 months
Title
Phase 2: Duration of Response (DOR)
Description
DOR was calculated only for participants who achieve a response (CMR or PMR). The duration was calculated from the date a response, CMR or PMR, was first achieved until the earliest date of a disease assessment indicating disease progression or death, whichever occured first. DOR was estimated using Kaplan-Meier method.
Time Frame
From first dose of blinatumomab up to 12 weeks
Title
Phase 2: Percentage of Participants Who Experienced Successful Mobilization
Description
Successful mobilization rate was defined as the percentage of participants who initiated mobilization while in remission and without any other anti-tumor therapy where the mobilization procedure had an outcome of 'Successful'. Successful mobilization was dictated by institutional standards and defined when the target cell dose was no less than 2 x 10^6 CD34+ cells/kg.
Time Frame
From first dose of blinatumomab until the end of study, up to 30 months
Title
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Description
The percentage of responders per investigator's review (participants who achieved either CMR or PMR during the treatment) who have undergone allogeneic (allo) HSCT or autologous (auto) HSCT while in remission and without any other anti-cancer treatment.
Time Frame
From baseline HSCT until the end of study, up to 30 months
Title
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events
Description
Non-relapse mortality rate at 100 days after HSCT was calculated as the percentage of participants who died not due to relapse. Only participants who achieved a response per investigator's review and underwent autoHSCT are included.
Time Frame
100 days after HSCT
Title
Phase 2: Blinatumomab Steady State Concentrations (Css)
Description
Pharmacokinetic (PK) parameters were estimated by non compartmental analysis. The Css of blinatumomab was summarized as the observed concentrations collected after at least 24 hours after the start of continuous IV infusion or start of dose step, where appropriate.
Time Frame
Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Title
Phase 2: Blinatumomab Clearance (CL)
Description
Serum blinatumomab CL was calculated as CL=R0/Css,DN; where R0 is the infusion rate (μg/hr) and Css,DN is the dose normalized average Css. For the CL calculation, the Css,DN was normalized to the 112 μg/day dose in which the value of dose in units of μg/hr was used for the infusion rate.
Time Frame
Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Title
Phase 2: Half-life of Blinatumomab
Time Frame
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Title
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Description
Treatment-emergent adverse events were events with an onset after the administration of the first dose of blinatumomab. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Time Frame
From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days
Title
Phase 3: Objective Response Rate (ORR)
Time Frame
Up to 12 weeks after first dose of study treatment
Title
Phase 3: Progression Free Survival (PFS)
Time Frame
From first dose of study treatment until the end of study, up to 30 months
Title
Phase 3: Duration of Response (DOR)
Time Frame
From first dose of study treatment up to 12 weeks
Title
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Time Frame
From baseline until the end of study, up to 30 months
Title
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Time Frame
From baseline HSCT until the end of study, up to 30 months
Title
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Time Frame
100 days after HSCT
Title
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Time Frame
Up to 30 days after last dose after study treatment
Title
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time Frame
From first dose of study treatment until 30 days after last dose
Title
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Time Frame
24 hours after first dose of blinatumomab
Title
Phase 3: Blinatumomab Clearance (CL)
Time Frame
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Title
Phase 3: Half-life of Blinatumomab
Time Frame
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible: Lymphoblastic lymphoma Burkitt lymphoma Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor. Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy Biopsy proven confirmation of relapsed disease. Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy. Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension Eastern Cooperative Oncology Group performance status less than or equal to 2 Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT) Laboratory parameters: Hematology: Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L Platelets ≥ 75 x 10^9/L Chemistry: Creatinine clearance ≥ 50 mL/min Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN) Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma) Exclusion Criteria: CMR following S1 chemotherapy Treatment within 30 days prior to randomization with another investigational device or drug study (ies). Prior anti-CD19-directed therapies Prior HDT with autologous HSCT Prior allogeneic HSCT Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis Evidence of CNS involvement by NHL Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive) History of malignancy other than B-NHL within the past 3 years with the exception of: Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment Adequately treated non-melanoma skin cancer or lentigo maligna Adequately treated cervical carcinoma in situ Adequately treated breast ductal carcinoma in situ Prostatic intraepithelial neoplasia without evidence of prostate cancer Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ Known sensitivity to immunoglobulins or any of the components to be administered during dosing. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Research Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Research Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Research Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Valladolid
State/Province
Castilla León
ZIP/Postal Code
47012
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
32546071
Citation
Coyle L, Morley NJ, Rambaldi A, Mason KD, Verhoef G, Furness CL, Zhang A, Jung AS, Cohan D, Franklin JL. Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma. 2020 Sep;61(9):2103-2112. doi: 10.1080/10428194.2020.1759055. Epub 2020 Jun 16.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

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