Back to resultsA Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Primary Purpose
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Relapsed or Refractory Follicular Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, EPCORE
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:
- Participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
- Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Must have 1 or more measurable disease sites:
- Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
- FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Adequate organ function.
Exclusion Criteria:
- Central nervous system (CNS) involvement.
Sites / Locations
- University of Arkansas for Medical Sciences /ID# 244562Recruiting
- Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133Recruiting
- Rocky Mountain Cancer Centers /ID# 247653Recruiting
- Bennett Cancer Center - Stamford Hospital /ID# 244530Recruiting
- Mount Sinai Medical Center-Miami Beach /ID# 249045Recruiting
- Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432Recruiting
- Cleveland Clinic Florida /ID# 244532Recruiting
- University of Illinois - Chicago /ID# 245038Recruiting
- Illinois Cancer Specialists /ID# 247655Recruiting
- Parkview Cancer Institute /ID# 244545Recruiting
- Indiana Blood & Marrow Transpl /ID# 244971Recruiting
- American Oncology Partners of Maryland, PA /ID# 244968Recruiting
- Maryland Oncology Hematology /ID# 254192Recruiting
- Tufts Medical Center /ID# 246074Recruiting
- Massachusetts General Hospital /ID# 245239Recruiting
- Beth Israel Deaconess Medical Center /ID# 248651Recruiting
- Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547Recruiting
- Hattiesburg Clinic /ID# 244980Recruiting
- St. Luke's Hospitals /ID# 247815Recruiting
- Dartmouth-Hitchcock Medical Center /ID# 245003Recruiting
- Morristown Medical Center /ID# 244973Recruiting
- University of New Mexico /ID# 252434Recruiting
- Stony Brook University Medical Center /ID# 244631Recruiting
- Wake Forest Univ HS /ID# 245005Recruiting
- Oncology Hematology Care, Inc. /ID# 246182Recruiting
- Toledo Clinic Cancer Center /ID# 246852Recruiting
- University of Oklahoma, Stephenson Cancer Center /ID# 244568Recruiting
- Willamette Valley Cancer Institute and Research Center /ID# 246410Recruiting
- Lehigh Valley Hospital-Cedar Crest /ID# 244984Recruiting
- Penn State Milton S. Hershey Medical Center /ID# 244979Recruiting
- UPMC Hillman Cancer Ctr /ID# 244571Recruiting
- Prisma Health Cancer Institute-Faris Road /ID# 247654Recruiting
- The West Clinic /ID# 245004Recruiting
- Texas Oncology - Austin Midtown /ID# 247656Recruiting
- Texas Oncology - San Antonio Medical Center /ID# 247658Recruiting
- Texas Oncology - Northeast Texas /ID# 247657Recruiting
- Virginia Cancer Specialists - Gainesville /ID# 248760Recruiting
- Northwest Medical Specialties - Tacoma /ID# 245045Recruiting
- Pan American Center for Oncology Trials, LLC /ID# 254952Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)
Main Cohort: Epcoritamab Follicular Lymphoma (FL)
Diversity Enriched Cohort: Epcoritamab DLBCL
Diversity Enriched Cohort: Epcoritamab FL
Arm Description
Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events
Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.
Secondary Outcome Measures
Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment
BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.
CR Determined by Lugano 2014 Criteria Per Investigator Assessment
Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Diversity Enriched Cohort: Severity of TEAEs by Severity Level
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Diversity Enriched Cohort: Severity of SAEs by Severity Level
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher
Median time to onset of CRS of Grade 3 or higher.
Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher
Median time to resolution of CRS of Grade 3 or higher.
Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher
Median time to onset of ICANS of Grade 3 or higher.
Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher
Median time to resolution of ICANS of Grade 3 or higher.
Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher
Median time to onset of Ntox of Grade 3 or higher.
Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher
Median time to resolution of Ntox of Grade 3 or higher.
Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab
Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab
Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab
Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.
Diversity Enriched Cohort: Duration of response (DOR)
Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Diversity Enriched Cohort: Progression-free survival (PFS)
Progression-free survival is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Diversity Enriched Cohort: Overall survival (OS)
Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.
Diversity Enriched Cohort: Time-to-response (TTR)
Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.
Diversity Enriched Cohort: Duration of CR (DOCR)
The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.
Diversity Enriched Cohort: Time to Next Treatment
Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.
Full Information
NCT ID
NCT05451810
First Posted
July 6, 2022
Last Updated
October 9, 2023
Sponsor
AbbVie
Collaborators
Genmab
1. Study Identification
Unique Protocol Identification Number
NCT05451810
Brief Title
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Official Title
A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
August 29, 2027 (Anticipated)
Study Completion Date
May 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genmab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) or R/R follicular lymphoma (FL). Adverse events will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 80 sites in the United States of America.
Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Keywords
Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Relapsed or Refractory Follicular Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, EPCORE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)
Arm Type
Experimental
Arm Description
Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Arm Title
Main Cohort: Epcoritamab Follicular Lymphoma (FL)
Arm Type
Experimental
Arm Description
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Arm Title
Diversity Enriched Cohort: Epcoritamab DLBCL
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Arm Title
Diversity Enriched Cohort: Epcoritamab FL
Arm Type
Experimental
Arm Description
Participants with R/R FL will receive SC epcoritamab in 28 day cycles.
Intervention Type
Drug
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
ABBV-GMAB-3013
Intervention Description
Subcutaneous Injection (SC)
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events
Description
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Time Frame
Up to 3 Months
Title
Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Description
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Time Frame
Up to 3 Months
Title
Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events
Description
Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.
Time Frame
Up to 3 Months
Secondary Outcome Measure Information:
Title
Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment
Description
BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.
Time Frame
Up to 3 Months
Title
CR Determined by Lugano 2014 Criteria Per Investigator Assessment
Description
Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level
Description
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Severity of TEAEs by Severity Level
Description
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level
Description
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Severity of SAEs by Severity Level
Description
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher
Description
Median time to onset of CRS of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher
Description
Median time to resolution of CRS of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher
Description
Median time to onset of ICANS of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher
Description
Median time to resolution of ICANS of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher
Description
Median time to onset of Ntox of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher
Description
Median time to resolution of Ntox of Grade 3 or higher.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s
Description
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab
Description
Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab
Description
Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab
Description
Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Duration of response (DOR)
Description
Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Progression-free survival (PFS)
Description
Progression-free survival is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Overall survival (OS)
Description
Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Time-to-response (TTR)
Description
Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Duration of CR (DOCR)
Description
The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.
Time Frame
Up to 3 Months
Title
Diversity Enriched Cohort: Time to Next Treatment
Description
Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.
Time Frame
Up to 3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:
Can include participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Has measurable disease as defined below:
-- Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate organ function.
Exclusion Criteria:
- Central nervous system (CNS) involvement by lymphoma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences /ID# 244562
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-7501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(714) 698-0300
Facility Name
Rocky Mountain Cancer Centers /ID# 247653
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Individual Site Status
Recruiting
Facility Name
Bennett Cancer Center - Stamford Hospital /ID# 244530
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-3602
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center-Miami Beach /ID# 249045
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140-2948
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028-1023
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Florida /ID# 244532
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3609
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Illinois - Chicago /ID# 245038
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Cancer Specialists /ID# 247655
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkview Cancer Institute /ID# 244545
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845-1739
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
1-833-724-8326
Facility Name
Indiana Blood & Marrow Transpl /ID# 244971
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA /ID# 244968
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
301-571-2016
Facility Name
Maryland Oncology Hematology /ID# 254192
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044-3128
Country
United States
Individual Site Status
Recruiting
Facility Name
Tufts Medical Center /ID# 246074
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital /ID# 245239
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center /ID# 248651
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197-1051
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic /ID# 244980
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
601-261-1700
Facility Name
St. Luke's Hospitals /ID# 247815
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017-3406
Country
United States
Individual Site Status
Recruiting
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 245003
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Morristown Medical Center /ID# 244973
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico /ID# 252434
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-4517
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center /ID# 244631
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Univ HS /ID# 245005
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology Care, Inc. /ID# 246182
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-2725
Country
United States
Individual Site Status
Recruiting
Facility Name
Toledo Clinic Cancer Center /ID# 246852
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma, Stephenson Cancer Center /ID# 244568
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5418
Country
United States
Individual Site Status
Recruiting
Facility Name
Willamette Valley Cancer Institute and Research Center /ID# 246410
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-6043
Country
United States
Individual Site Status
Recruiting
Facility Name
Lehigh Valley Hospital-Cedar Crest /ID# 244984
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103-6202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
610-402-9543
Facility Name
Penn State Milton S. Hershey Medical Center /ID# 244979
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Hillman Cancer Ctr /ID# 244571
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health Cancer Institute-Faris Road /ID# 247654
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4255
Country
United States
Individual Site Status
Recruiting
Facility Name
The West Clinic /ID# 245004
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
901-683-0055
Facility Name
Texas Oncology - Austin Midtown /ID# 247656
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - San Antonio Medical Center /ID# 247658
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-5251
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Northeast Texas /ID# 247657
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists - Gainesville /ID# 248760
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155-3257
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties - Tacoma /ID# 245045
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Pan American Center for Oncology Trials, LLC /ID# 254952
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-362
Description
Related info
Learn more about this trial
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
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