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
- Registration Number
- NCT05206357
- Lead Sponsor
- Genmab
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17
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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.
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Disease pathologically confirmed (tumor tissue) by local testing.
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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.
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Recovery from toxic effects of prior chemoimmunotherapy.
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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 .
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Adequate bone marrow, hepatic, and renal function.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epcoritamab Epcoritamab Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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).
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.
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.
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.
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.
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).
Trial Locations
- Locations (41)
CHU Sainte-Justine /ID# 240766
🇨🇦Montreal, Quebec, Canada
National Cancer Center Hospital /ID# 246722
🇯🇵Chuo-ku, Tokyo, Japan
Lucile Packard Children's Hospital /ID# 240854
🇺🇸Palo Alto, California, United States
Nicklaus Children's Hospital /ID# 241174
🇺🇸Miami, Florida, United States
New York Medical College /ID# 239208
🇺🇸Valhalla, New York, United States
Levine Children's Hospital /ID# 242765
🇺🇸Charlotte, North Carolina, United States
Cincinnati Childrens Hospital Medical Center /ID# 239823
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia - Main /ID# 239294
🇺🇸Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital /ID# 239184
🇺🇸Memphis, Tennessee, United States
University of Texas Southwestern Medical Center /ID# 240892
🇺🇸Dallas, Texas, United States
Children's Hospital at Westmead /ID# 240091
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital /ID# 240384
🇦🇺Parkville, Victoria, Australia
Perth Children'S Hospital /ID# 240382
🇦🇺Perth, Western Australia, Australia
Universitair Ziekenhuis Leuven /ID# 242384
🇧🇪Leuven, Vlaams-Brabant, Belgium
Hospital for Sick Children /ID# 240767
🇨🇦Toronto, Ontario, Canada
Fakultní Nemocnice Brno - Jihlavská /ID# 239956
🇨🇿Brno, Brno-mesto, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 239957
🇨🇿Prague, Czechia
CHU Bordeaux - Hopital Pellegrin /ID# 240832
🇫🇷Bordeaux, Nouvelle-Aquitaine, France
CHU de Nantes, Hotel Dieu -HME /ID# 240831
🇫🇷Nantes, Pays-de-la-Loire, France
Institut Gustave Roussy /ID# 240966
🇫🇷Villejuif Cedex, Val-de-Marne, France
Hospices Civils de Lyon /ID# 240834
🇫🇷Lyon, France
Universitaetsklinikum Erlangen /ID# 240861
🇩🇪Erlangen, Bayern, Germany
Universitaetsklinikum Giessen und Marburg /ID# 240787
🇩🇪Marburg, Hessen, Germany
Universitaetsklinikum Muenster /ID# 239970
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Rambam Health Care Campus /ID# 240037
🇮🇱Haifa, H_efa, Israel
Schneider Children's Medical Center /ID# 240171
🇮🇱Petah Tikva, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 240670
🇮🇱Ramat Gan, Tel-Aviv, Israel
Azienda Ospedaliero Universitaria Meyer /ID# 240049
🇮🇹Florence, Firenze, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 245592
🇮🇹Monza, Monza E Brianza, Italy
Ospedale Pediatrico Bambino Gesù /ID# 240039
🇮🇹Rome, Roma, Italy
NHO Nagoya Medical Center /ID# 246680
🇯🇵Nagoya-shi, Aichi, Japan
Kyoto University Hospital /ID# 246907
🇯🇵Kyoto-shi, Kyoto, Japan
Samsung Medical Center /ID# 239895
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Sant Joan de Deu /ID# 240719
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron /ID# 240715
🇪🇸Barcelona, Spain
Hospital Infantil Universitario Nino Jesus /ID# 240717
🇪🇸Madrid, Spain
National Taiwan University Hospital /ID# 242890
🇨🇳Taipei City, Taipei, Taiwan
Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
🇹🇷Istanbul, Turkey
Osaka City General Hospital /ID# 246906
🇯🇵Osaka-shi, Osaka, Japan
National Center for Child Health and Development /ID# 246658
🇯🇵Setagaya-ku, Tokyo, Japan
Seoul National University Hospital /ID# 239894
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of