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
NCT ID: NCT05206357
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
17 participants
INTERVENTIONAL
2022-10-04
2028-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epcoritamab
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Interventions
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Epcoritamab
Subcutaneous Injection (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
25 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
CHU Sainte-Justine /ID# 240766
Montreal, Quebec, 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 Region, France
Institut Gustave Roussy /ID# 240966
Villejuif, Val-de-Marne, France
Hospices Civils de Lyon /ID# 240834
Lyon, , France
Universitaetsklinikum Erlangen /ID# 240861
Erlangen, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg /ID# 240787
Marburg, Hesse, Germany
Universitaetsklinikum Muenster /ID# 239970
Münster, North Rhine-Westphalia, Germany
Schneider Children's Medical Center /ID# 240171
Petah Tikva, Central District, Israel
Rambam Health Care Campus /ID# 240037
Haifa, H_efa, 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, Aichi-ken, Japan
Kyoto University Hospital /ID# 246907
Kyoto, Kyoto, Japan
Osaka City General Hospital /ID# 246906
Osaka, Osaka, Japan
National Cancer Center Hospital /ID# 246722
Chuo-ku, Tokyo, Japan
National Center for Child Health and Development /ID# 246658
Setagaya-ku, Tokyo, Japan
Seoul National University Hospital /ID# 239894
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 239895
Seoul, Seoul Teugbyeolsi, South Korea
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 (Türkiye)
Countries
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Other Identifiers
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2021-004555-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-429
Identifier Type: -
Identifier Source: org_study_id
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