Clinical trial NCT05206357: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Genmab
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2022-01-25
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Approximately 3 Years
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to Approximately Week 37
measure: Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
timeFrame: Up to Approximately Week 37
Secondary outcomes:
measure: Percentage of Participants who Achieve Complete Response (CR)
timeFrame: Up to Approximately 1 Year
measure: Number of Participants with Event-free survival (EFS)
timeFrame: Up to Approximately 3 Years
measure: Number of Participants who Achieve Overall Survival (OS)
timeFrame: Up to Approximately 3 Years
measure: Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
timeFrame: Up to Approximately 1 Year
measure: Percentage of Participants Achieving Overall Response (OR)
timeFrame: Up to Approximately 1 Year
measure: Duration of response (DOR)
timeFrame: Up to Approximately 1 Year
measure: Duration of CR (DOCR)
timeFrame: Up to Approximately 1 Year
measure: Percentage of Participants Achieving Immunogenicity
timeFrame: Up to Approximately Week 37
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital /ID# 240854
state: California
city: Miami
country: United States
facility: Nicklaus Children's Hospital /ID# 241174
state: Florida
city: Valhalla
country: United States
facility: New York Medical College /ID# 239208
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital /ID# 242765
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center /ID# 239823
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 239294
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude Children's Research Hospital /ID# 239184
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 240892
state: Texas
city: Westmead
country: Australia
facility: Children's Hospital at Westmead /ID# 240091
state: New South Wales
city: Parkville
country: Australia
facility: Royal Children's Hospital /ID# 240384
state: Victoria
city: Perth
country: Australia
facility: Perth Children'S Hospital /ID# 240382
state: Western Australia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 242384
state: Vlaams-Brabant
city: Toronto
country: Canada
facility: Hospital for Sick Children /ID# 240767
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine /ID# 240766
state: Quebec
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno - Jihlavská /ID# 239956
state: Brno-mesto
city: Prague
country: Czechia
facility: Duplicate_Fakultni Nemocnice v Motole /ID# 239957
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 240832
state: Nouvelle-Aquitaine
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 240831
state: Pays-de-la-Loire
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy /ID# 240966
state: Val-de-Marne
city: Lyon
country: France
facility: Hospices Civils de Lyon /ID# 240834
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 240861
state: Bayern
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg /ID# 240787
state: Hessen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 239970
state: Nordrhein-Westfalen
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 240037
state: H_efa
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center /ID# 240171
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 240670
state: Tel-Aviv
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer /ID# 240049
state: Firenze
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 245592
state: Monza E Brianza
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù /ID# 240039
state: Roma
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 246680
state: Aichi
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 246907
state: Kyoto
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 246906
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 246722
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 246658
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 239894
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 239895
state: Seoul Teugbyeolsi
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 240719
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 240715
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus /ID# 240717
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 242890
state: Taipei
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: