Non Hodgkin Lymphoma Clinical 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

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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT05206357

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 40 Locations for this study

See Locations Near You

Lucile Packard Children's Hospital /ID# 240854
Palo Alto California, 94304, United States
Nicklaus Children's Hospital /ID# 241174
Miami Florida, 33155, United States
New York Medical College /ID# 239208
Valhalla New York, 10595, United States
Levine Children's Hospital /ID# 242765
Charlotte North Carolina, 28203, United States
Cincinnati Childrens Hospital Medical Center /ID# 239823
Cincinnati Ohio, 45229, United States
Children's Hospital of Philadelphia - Main /ID# 239294
Philadelphia Pennsylvania, 19104, United States
St Jude Children's Research Hospital /ID# 239184
Memphis Tennessee, 38105, United States
University of Texas Southwestern Medical Center /ID# 240892
Dallas Texas, 75390, United States
Royal Children's Hospital /ID# 240384
Parkville Victoria, 3052, Australia
Perth Children's Hospital /ID# 240382
Nedlands Western Australia, 6009, Australia
Children's Hospital at Westmead /ID# 240091
Westmead , 2145, Australia
Universitair Ziekenhuis Leuven /ID# 242384
Leuven Vlaams-Brabant, 3000, Belgium
Hospital for Sick Children /ID# 240767
Toronto Ontario, M5G 1, Canada
CHU Sainte-Justine /ID# 240766
Montreal Quebec, H3T 1, Canada
Fakultni nemocnice Brno /ID# 239956
Brno , 613 0, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 239957
Prague , 150 0, Czechia
CHU Bordeaux - Hopital Pellegrin /ID# 240832
Bordeaux CEDEX Gironde, 33076, France
CHU de Nantes, Hotel Dieu -HME /ID# 240831
Nantes Pays-de-la-Loire, 44000, France
Institut Gustave Roussy /ID# 240966
Villejuif Cedex Val-de-Marne, 94805, France
Hospices Civils de Lyon /ID# 240834
Lyon , 69003, France
Universitaetsklinikum Erlangen /ID# 240861
Erlangen Bayern, 91054, Germany
Universitaetsklinikum Muenster /ID# 239970
Muenster Nordrhein-Westfalen, 48149, Germany
Universitaetsklinikum Giessen und Marburg /ID# 240787
Marburg , 35043, Germany
Rambam Health Care Campus /ID# 240037
Haifa H_efa, 31096, Israel
Schneider Children's Medical Center /ID# 240171
Petah Tikva HaMerkaz, 49202, Israel
The Chaim Sheba Medical Center /ID# 240670
Ramat Gan Tel-Aviv, 52656, Israel
Azienda Ospedaliero Universitaria Meyer /ID# 240049
Florence Firenze, 50139, Italy
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039
Rome Roma, 00165, Italy
NHO Nagoya Medical Center /ID# 246680
Nagoya-shi Aichi, 460-0, Japan
Kyoto University Hospital /ID# 246907
Kyoto-shi Kyoto, 606-8, Japan
Osaka City General Hospital /ID# 246906
Osaka-shi Osaka, 534-0, Japan
National Cancer Center Hospital /ID# 246722
Chuo-ku Tokyo, 104-0, Japan
National Center for Child Health and Development /ID# 246658
Setagaya-ku Tokyo, 157-8, Japan
Seoul National University Hospital /ID# 239894
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 239895
Seoul , 06351, Korea, Republic of
Hospital Sant Joan de Deu /ID# 240719
Esplugues de Llobregat Barcelona, 08950, Spain
Hospital Universitario Vall d'Hebron /ID# 240715
Barcelona , 08035, Spain
Hospital Infantil Universitario Nino Jesus /ID# 240717
Madrid , 28009, Spain
National Taiwan University Hospital /ID# 242890
Taipei City , 100, Taiwan
Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
Istanbul , 34010, Turkey

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT05206357

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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