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A Study to Evaluate 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
Not Recruiting
Trial ID: NCT04980222
Purpose
This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and
pharmacokinetics of glofitamab in combination with rituximab in combination with
cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with
circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first
line of treatment.
Official Title
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
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Eligibility
Inclusion Criteria:
- 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
- DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well as
double-expressor lymphoma (coexpression of MYC and BCL2)
- High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 translocations
- Patients with de novo transformed follicular lymphoma (patients with discordant
bone marrow involvement, i.e., evidence of low-grade histology in bone marrow)
may be considered after discussion with the Medical Monitor
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- International Prognostic Index (IPI): 2-5
- 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) >=50%, as determined on cardiac
multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematopoietic function
- Contraception use
Additional Inclusion Criterion for ctDNA High-Risk Participants:
- Plasma sample evaluated to be ctDNA high risk
Exclusion Criteria:
- 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
Intervention(s):
drug: Glofitamab
drug: Tocilizumab
drug: Doxorubicin
drug: Vincristine
drug: Prednisone
drug: Rituximab
drug: Cyclophosphamide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Austin Yeung
ahyeung@stanford.edu