Informations générales (source: ClinicalTrials.gov)

NCT05283720 En recrutement IDF
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
Interventional
  • Lymphomes
  • Lymphome malin non hodgkinien
Phase 1/Phase 2
Genmab (Voir sur ClinicalTrials)
juin 2022
novembre 2032
06 juin 2025
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 565 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in PPTS with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in PPTS with newly diagnosed treatment-naïve MCL. 8: Oral pirtobrutinib in PPTS with R/R MCL. 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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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Henri Mondor-Albert Chenevier En recrutement IDF Contact (sur clinicalTrials)
AP-HP - Hôpital La Pitié-Salpêtrière En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHRU Lille - Hopital Claude Huriez /ID# 242335 - 59037 - Lille - Nord - France En recrutement Contact (sur clinicalTrials)
CHRU Nancy - Hopitaux de Brabois /ID# 242342 - 54500 - Vandoeuvre-les-Nancy - Meurthe-et-Moselle - France En recrutement Contact (sur clinicalTrials)
CHU Clermont-Ferrand /ID# 242344 - 63100 - Clermont - Auvergne-Rhone-Alpes - France En recrutement Contact (sur clinicalTrials)
CHU de Nantes, Hotel Dieu -HME /ID# 242345 - 44000 - Nantes - Pays-de-la-Loire - France En recrutement Contact (sur clinicalTrials)
CHU de Rennes - PONTCHAILLOU /ID# 242339 - 35000 - Rennes - Bretagne - France En recrutement Contact (sur clinicalTrials)
HCL - Hopital Lyon Sud /ID# 242349 - 69495 - Pierre Benite CEDEX - Rhone - France En recrutement Contact (sur clinicalTrials)
Hôpital Saint-Louis /ID# 242336 - 75010 - Paris - France En recrutement Contact (sur clinicalTrials)
IUCT Oncopole /ID# 242340 - 31059 - Toulouse Cedex 9 - Occitanie - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Diagnosis of:

-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from
follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically
confirmed CD20+ disease, inclusive of the following according to World Health
Organization (WHO) 2016 classification and documented in pathology report:

- DLBCL, not otherwise specified (NOS).

- High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per
WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS
or other double- /triple-hit lymphomas (with histologies not consistent with
DLBCL) are not eligible.

- Follicular lymphoma (FL) Grade 3B. OR

- FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic
transformation to an aggressive lymphoma at most recent representative tumor biopsy,
according to WHO 2016 classification. OR

- Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most
recent representative tumor biopsy according to the WHO 2016 classification with
evidence of overexpression of cyclin D1 in association with relevant markers or
evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization
(FISH), or polymerase chain reaction (PCR).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms
6, 7, and 8 where ECOG performance status must be 0-1.

- Must have 1 or more measurable disease sites:

- A positron emission tomography (PET) /computed tomography (CT) scan
demonstrating PET-positive lesion(s) AND

- At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable
extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance
imaging (MRI).


- Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and
CD20.

- Toxicities from prior anticancer therapy that have not resolved to Common
Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the
exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac
criteria) must also be met.