JRCT ID: jRCT2011220044
Registered date:14/03/2023
[M22-132] 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
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | B-cell non-Hodgkin lymphoma |
Date of first enrollment | 28/08/2023 |
Target sample size | 132 |
Countries of recruitment | United States,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Korea,Japan,Netherlands,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan |
Study type | Interventional |
Intervention(s) | - Arm 2: Dose Expansion Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles. - Arm 3: Dose Expansion Participants newly diagnosed treatment-naive DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles. |
Outcome(s)
Primary Outcome | Dose Limiting Toxicities (DLTs) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Diagnosis of diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma 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 Grade 3B. -Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. -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 >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI. |
Exclude criteria | -Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20. -Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. |
Related Information
Primary Sponsor | Satomi Natsuko |
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Secondary Sponsor | Genmab K.K. |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05283720 |
Contact
Public contact | |
Name | Contact for Patients and HCP |
Address | 3-1-21, Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie G.K. |
Scientific contact | |
Name | Natsuko Satomi |
Address | 3-1-21, Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie G.K. |