Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Genmab
Collaborating Sponsors:
AbbVie
Conditions:
Non-hodgkin Lymphoma
Eligibility:
All Genders
1-25 years
Phase:
PHASE1
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 malign...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2028
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05206357
Start Date
October 4 2022
End Date
November 1 2028
Last Update
April 8 2025
Active Locations (41)
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1
Lucile Packard Children's Hospital /ID# 240854
Palo Alto, California, United States, 94304
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