lymphatic disease Non-Hodgkin Lymphoma
Conditions
Interventions
In both the dose escalation and dose expansion arms participants will receive
subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm
in combination with the anti-neoplastic ag
2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL
3: Intravenous (IV) polatuzumab vedotin, IVrituximab, IV cyclophosphamide, IV
doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP)
inparticipants with newly diagnosed treatment-naïve DL
4: Oral CC-99282 in participants with R/R DLBCL
5: OralCC-99282 in participants with R/R follicular lymphoma (FL)
6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL)
6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL
7: Oral ibrutinib,and oral venetoclax in participants with newly diagnosed
treatment-naïve MCL.
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female, at least 18 years old 2. Diagnosis of DLBCL with histologically confirmed CD20+ disease, inclusive of the following according to 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 Grade 3B 3. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 4. Subject must have 1 or more measurable disease sites: • A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND • At least 1 measurable nodal lesion (long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI
Exclusion criteria
Exclusion criteria: 1.Diagnosis of High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) 2. Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is dose limiting toxicities (DLTs) of epcoritamab in combination with anti-neoplastic agents. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall Response Rate (ORR) by Lugano 2014 criteria (Appendix E) as assessed by investigator for epcoritamab in combination with other anti-neoplastic agents. • Anti-lymphoma activity of epcoritamab in combination with other anti-neoplastic agents: -Duration of response (DOR) determined per Lugano 2014 criteria as assessed by investigator -Progression free survival (PFS) determined per Lugano 2014 criteria as assessed by investigator -Complete Response (CR) rate determined per Lugano 2014 criteria as assessed by investigator -Time to response (TTR) determined per Lugano 2014 criteria as assessed by investigator -Time to next anti-lymphoma therapy (TTNT) -Rate of Minimal Residual Disease (MRD) negativity -Overall survival (OS) | — |
Countries
Netherlands
Outcome results
None listed