Informations générales (source: ClinicalTrials.gov)
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Interventional
Phase 1
Genmab (Voir sur ClinicalTrials)
octobre 2022
novembre 2028
09 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | V�ronique MINARD-COLIN | 06/06/2024 14:29:12 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Bordeaux - Hopital Pellegrin /ID# 240832 - 33076 - Bordeaux - Nouvelle-Aquitaine - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes, Hotel Dieu -HME /ID# 240831 - 44000 - Nantes - Pays-de-la-Loire - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon /ID# 240834 - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.