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
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

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