A PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY OF GLOFITAMAB IN COMBINATION WITH RITUXIMAB (R) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN CIRCULATING TUMOR (ct)DNA HIGH-RISK PATIENTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA
- Conditions
- B-cell lymphomalymph node cancer10025320
- Registration Number
- NL-OMON56027
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
• Age 18 years or older at the time of signing Informed Consent Form
• Previously untreated patients with CD20-positive DLBCL, including one of the
following diagnoses made according to the 2016 World Health Organization (WHO)
classification of lymphoid neoplasms
o DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well
as double-expressor lymphoma (coexpression of MYC and BCL2)
o High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6
translocations
o Patients with de novo transformed follicular lymphoma
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• International Prognostic Index (IPI): 1-5
• Life expectancy of at least 6 months
• Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of
Cycle 1 and on Day 1 of Cycle 2 submitted for screening for determination of
ctDNA status
• At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable
lymphoma lesion on positron emission tomography/computed tomography (PET/CT)
scan
• Left ventricular ejection fraction (LVEF) of at least 50%, as determined on
cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
• Negative HIV test at screening, with the following exception: Patients with a
positive HIV test at screening are eligible provided that, prior to enrollment,
they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4
count ³ 200/µL, have an undetectable viral load, and have not had a history of
an AIDS-defining opportunistic infection within the past 12 months.
• Adequate hematopoietic function
• Contraception use
Additional Inclusion Criterion for ctDNA High-Risk Participants
• Plasma sample evaluated to be ctDNA high risk using the experimental AOA*NHL
Test,, defined as <2-log fold reduction in ctDNA levels between Day 1 of Cycle
1 and Day 1 of Cycle 2 by central laboratory assessment
• Current diagnosis of B-cell lymphoma, unclassifiable, with features
intermediate between DLBCL and classic Hodgkin lymphoma (gray-zone lymphoma),
primary mediastinal (thymic) large B-cell lymphoma, T-cell/histiocyte-rich
large B*cell lymphoma, Burkitt lymphoma, central nervous system (CNS) lymphoma
(primary or secondary involvement), primary effusion DLBCL, and primary
cutaneous DLBCL
• Contraindication to any of the individual components of R-CHOP, including
prior receipt of anthracyclines, history of severe allergic or anaphylactic
reactions to murine monoclonal antibodies, or known sensitivity or allergy to
murine products
• Prior treatment for indolent lymphoma
• Prior solid organ or allogeneic stem cell transplant
• Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the
exception of palliative, short-term treatment with corticosteroids
• Pregnant or breastfeeding, or intending to become pregnant during the study
or within 12 months after the final dose of R-CHOP, 3 months after the final
dose of tocilizumab (if applicable), or 2 months after the final dose of
glofitamab
• An exclusion criterion of a positive SARS-CoV-2 test within 7 days prior to
enrollment (including rapid antigen test) has been added
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method