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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05206357

Collaborator

Genmab (Industry)

Enrollment

Locations

Arm

60.4

Anticipated Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma	Drug: Epcoritamab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

Actual Study Start Date :

Jun 7, 2022

Anticipated Primary Completion Date :

Jun 18, 2027

Anticipated Study Completion Date :

Jun 18, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epcoritamab Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.	Drug: Epcoritamab Subcutaneous Injection (SC) Other Names: ABBV-GMAB-3013

Arm

Intervention/Treatment

Experimental: Epcoritamab

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Drug: Epcoritamab

Subcutaneous Injection (SC)

Other Names:

ABBV-GMAB-3013

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events (AE) [Up to Approximately 3 Years]
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) [Up to Approximately Week 37]
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) [Up to Approximately Week 37]
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) [Up to Approximately 1 Year]
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) [Up to Approximately 3 Years]
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) [Up to Approximately 3 Years]
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 [Up to Approximately 1 Year]
Rate of initiation of stem cell transplantation or CAR-T therapy.
Percentage of Participants Achieving Overall Response (OR) [Up to Approximately 1 Year]
OR is assessed as the percentage of participants with an overall response.
Duration of response (DOR) [Up to Approximately 1 Year]
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) [Up to Approximately 1 Year]
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 [Up to Approximately Week 37]
Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lucile Packard Children's Hospitals - Stanford /ID# 240854	Palo Alto	California	United States	94304-5786
2	Nicklaus Children's Hospital /ID# 241174	Miami	Florida	United States	33155-3009
3	New York Medical College /ID# 239208	Valhalla	New York	United States	10595
4	Levine Children's Hospital /ID# 242765	Charlotte	North Carolina	United States	28203-5812
5	Cincinnati Childrens Hospital Medical Center /ID# 239823	Cincinnati	Ohio	United States	45229
6	Oregon Health & Science University /ID# 240090	Portland	Oregon	United States	97239-3011
7	Children's Hospital of Philadelphia - Main /ID# 239294	Philadelphia	Pennsylvania	United States	19104-4319
8	St Jude Children's Research Hospital /ID# 239184	Memphis	Tennessee	United States	38105
9	University of Texas Southwestern Medical Center /ID# 240892	Dallas	Texas	United States	75390-7208
10	Medical College of Wisconsin - Plank Rd /ID# 239782	Milwaukee	Wisconsin	United States	53226-3548
11	The Children's Hospital at Westmead /ID# 240091	Sydney	New South Wales	Australia	2145
12	Royal Children's Hospital /ID# 240384	Parkville	Victoria	Australia	3052
13	Perth Children's Hospital /ID# 240382	Nedlands	Western Australia	Australia	6009
14	Universitair Ziekenhuis Leuven /ID# 242384	Leuven	Vlaams-Brabant	Belgium	3000
15	Hospital for Sick Children /ID# 240767	Toronto	Ontario	Canada	M5G 1X8
16	CHU Sainte-Justine /ID# 240766	Montreal	Quebec	Canada	H3T 1C5
17	Fakultni Nemocnice Brno /ID# 239956	Brno		Czechia	625 00
18	CHU de Nantes, Hotel Dieu -HME /ID# 240831	Nantes	Pays-de-la-Loire	France	44000
19	Institut Gustave Roussy /ID# 240966	Villejuif Cedex	Val-de-Marne	France	94805
20	CHU Bordeaux - Hopital Pellegrin /ID# 240832	Bordeaux		France	33000
21	Hospices Civils de Lyon /ID# 240834	Lyon		France	69003
22	Universitaetsklinikum Erlangen /ID# 240861	Erlangen	Bayern	Germany	91054
23	Universitaetsklinikum Muenster /ID# 239970	Muenster	Nordrhein-Westfalen	Germany	48149
24	Universitaetsklinikum Giessen und Marburg /ID# 240787	Marburg		Germany	35043
25	Universitaetsmedizin Rostock /ID# 240891	Rostock		Germany	18057
26	The Chaim Sheba Medical Center /ID# 240670	Ramat Gan	Tel-Aviv	Israel	5265601
27	Rambam Health Care Campus /ID# 240037	Haifa		Israel	3109601
28	Schneider Children's Medical Center /ID# 240171	Petah Tikva		Israel	4920235
29	IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039	Rome	Lazio	Italy	00165
30	Comitato Maria Letizia Verga /ID# 245592	Monza MB	Monza E Brianza	Italy	20900
31	Azienda Ospedaliero Universitaria Meyer /ID# 240049	Florence		Italy	50139
32	NHO Nagoya Medical Center /ID# 246680	Nagoya-shi	Aichi	Japan	460-0001
33	Kyoto University Hospital /ID# 246907	Kyoto-shi	Kyoto	Japan	606-8507
34	Osaka City General Hospital /ID# 246906	Osaka-shi	Osaka	Japan	534-0021
35	National Cancer Center Hospital /ID# 246722	Chuo-ku	Tokyo	Japan	104-0045
36	National Center for Child Health and Development /ID# 246658	Setagaya-ku	Tokyo	Japan	157-8535
37	Seoul National University Hospital /ID# 239894	Seoul		Korea, Republic of	03080
38	Samsung Medical Center /ID# 239895	Seoul		Korea, Republic of	06351
39	Prinses Maxima Centrum /ID# 239815	Utrecht		Netherlands	3584 CS
40	Hospital Universitario Vall d'Hebron /ID# 240715	Barcelona		Spain	08035
41	Hospital Infantil Universitario Nino Jesus /ID# 240717	Madrid		Spain	28009
42	Hospital Universitario La Paz /ID# 240716	Madrid		Spain	28046
43	National Taiwan University Hospital /ID# 242890	Taipei City		Taiwan	100
44	Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026	Istanbul		Turkey	34010
45	Dokuz Eylul University Medical Faculty /ID# 239954	Izmir		Turkey	35340