Back to resultsStudy of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
Primary Purpose
Non-hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Sponsored by
About this trial
This is an interventional treatment trial for Non-hodgkin Lymphoma focused on measuring Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms, EPCORE
Eligibility Criteria
Inclusion Criteria:
- Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
- Disease pathologically confirmed (tumor tissue) by local testing.
Relapsed or primary refractory disease meeting any of the following criteria:
- Progressive disease at any time during second-line chemoimmunotherapy (CIT).
- Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
- Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
- Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
- Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
- Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
- Recovery from toxic effects of prior chemoimmunotherapy.
- Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
- Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:
- Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
- Other malignancy requiring therapy.
- Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
Sites / Locations
- Nicklaus Children's Hospital /ID# 241174Recruiting
- New York Medical College /ID# 239208Recruiting
- Levine Children's Hospital /ID# 242765Recruiting
- Cincinnati Childrens Hospital Medical Center /ID# 239823Recruiting
- Children's Hospital of Philadelphia - Main /ID# 239294Recruiting
- St Jude Children's Research Hospital /ID# 239184Recruiting
- Royal Children's Hospital /ID# 240384Recruiting
- Perth Children's Hospital /ID# 240382Recruiting
- Children's Hospital at Westmead /ID# 240091Recruiting
- Universitair Ziekenhuis Leuven /ID# 242384Recruiting
- Hospital for Sick Children /ID# 240767Recruiting
- CHU Sainte-Justine /ID# 240766Recruiting
- Fakultni Nemocnice Brno /ID# 239956Recruiting
- Fakultni Nemocnice v Motole /ID# 239957Recruiting
- CHU de Nantes, Hotel Dieu -HME /ID# 240831Recruiting
- Institut Gustave Roussy /ID# 240966Recruiting
- CHU Bordeaux - Hopital Pellegrin /ID# 240832Recruiting
- Hospices Civils de Lyon /ID# 240834Recruiting
- Universitaetsklinikum Erlangen /ID# 240861Recruiting
- Universitaetsklinikum Muenster /ID# 239970Recruiting
- Universitaetsklinikum Giessen und Marburg /ID# 240787Recruiting
- The Chaim Sheba Medical Center /ID# 240670Recruiting
- Rambam Health Care Campus /ID# 240037Recruiting
- Schneider Children's Medical Center /ID# 240171Recruiting
- Azienda Ospedaliero Universitaria Meyer /ID# 240049Recruiting
- IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039Recruiting
- NHO Nagoya Medical Center /ID# 246680Recruiting
- Kyoto University Hospital /ID# 246907Recruiting
- Osaka City General Hospital /ID# 246906Recruiting
- National Cancer Center Hospital /ID# 246722Recruiting
- National Center for Child Health and Development /ID# 246658Recruiting
- Seoul National University Hospital /ID# 239894Recruiting
- Samsung Medical Center /ID# 239895Recruiting
- Hospital Universitario Vall d'Hebron /ID# 240715Recruiting
- Hospital Infantil Universitario Nino Jesus /ID# 240717Recruiting
- National Taiwan University Hospital /ID# 242890Recruiting
- Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epcoritamab
Arm Description
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AE)
An AE 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.
Maximum Observed Concentration (Cmax)
Maximum observed concentration.
Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
AUC from time 0 to time of last measurable concentration within the dosing interval.
Secondary Outcome Measures
Percentage of Participants who Achieve Complete Response (CR)
CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).
Number of Participants with Event-free survival (EFS)
EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.
Number of Participants who Achieve Overall Survival (OS)
OS will be defined as the number of days from screening to the date of death from any cause.
Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Rate of initiation of stem cell transplantation or CAR-T therapy.
Percentage of Participants Achieving Overall Response (OR)
OR is assessed as the percentage of participants with an overall response.
Duration of response (DOR)
DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.
Duration of CR (DOCR)
DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.
Percentage of Participants Achieving Immunogenicity
Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).
Full Information
NCT ID
NCT05206357
First Posted
January 21, 2022
Last Updated
October 23, 2023
Sponsor
AbbVie
Collaborators
Genmab
1. Study Identification
Unique Protocol Identification Number
NCT05206357
Brief Title
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
Official Title
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
June 18, 2027 (Anticipated)
Study Completion Date
June 18, 2027 (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
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.
Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.
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
Non-hodgkin Lymphoma
Keywords
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms, EPCORE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epcoritamab
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (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
Number of Participants with Adverse Events (AE)
Description
An AE 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 Approximately 3 Years
Title
Maximum Observed Concentration (Cmax)
Description
Maximum observed concentration.
Time Frame
Up to Approximately Week 37
Title
Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
Description
AUC from time 0 to time of last measurable concentration within the dosing interval.
Time Frame
Up to Approximately Week 37
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve Complete Response (CR)
Description
CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).
Time Frame
Up to Approximately 1 Year
Title
Number of Participants with Event-free survival (EFS)
Description
EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.
Time Frame
Up to Approximately 3 Years
Title
Number of Participants who Achieve Overall Survival (OS)
Description
OS will be defined as the number of days from screening to the date of death from any cause.
Time Frame
Up to Approximately 3 Years
Title
Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Description
Rate of initiation of stem cell transplantation or CAR-T therapy.
Time Frame
Up to Approximately 1 Year
Title
Percentage of Participants Achieving Overall Response (OR)
Description
OR is assessed as the percentage of participants with an overall response.
Time Frame
Up to Approximately 1 Year
Title
Duration of response (DOR)
Description
DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.
Time Frame
Up to Approximately 1 Year
Title
Duration of CR (DOCR)
Description
DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.
Time Frame
Up to Approximately 1 Year
Title
Percentage of Participants Achieving Immunogenicity
Description
Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).
Time Frame
Up to Approximately Week 37
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
Disease pathologically confirmed (tumor tissue) by local testing.
Relapsed or primary refractory disease meeting any of the following criteria:
Progressive disease at any time during second-line chemoimmunotherapy (CIT).
Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
Recovery from toxic effects of prior chemoimmunotherapy.
Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:
Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
Other malignancy requiring therapy.
Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
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
Nicklaus Children's Hospital /ID# 241174
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3009
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Medical College /ID# 239208
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Children's Hospital /ID# 242765
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-5812
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Childrens Hospital Medical Center /ID# 239823
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia - Main /ID# 239294
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Individual Site Status
Recruiting
Facility Name
St Jude Children's Research Hospital /ID# 239184
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Children's Hospital /ID# 240384
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Perth Children's Hospital /ID# 240382
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Children's Hospital at Westmead /ID# 240091
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven /ID# 242384
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital for Sick Children /ID# 240767
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine /ID# 240766
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 239956
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice v Motole /ID# 239957
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 240831
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy /ID# 240966
City
Villejuif Cedex
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Pellegrin /ID# 240832
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon /ID# 240834
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Erlangen /ID# 240861
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster /ID# 239970
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Giessen und Marburg /ID# 240787
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 240670
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus /ID# 240037
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Schneider Children's Medical Center /ID# 240171
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Meyer /ID# 240049
City
Florence
State/Province
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039
City
Rome
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
NHO Nagoya Medical Center /ID# 246680
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital /ID# 246907
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka City General Hospital /ID# 246906
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital /ID# 246722
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Child Health and Development /ID# 246658
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 239894
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center /ID# 239895
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 240715
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Infantil Universitario Nino Jesus /ID# 240717
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital /ID# 242890
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
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