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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    40
  • sponsor
    Hoffmann-La Roche
Updated on 11 October 2022
cyclophosphamide
lymphoma
rituximab
vincristine
prednisone
bone marrow procedure
prednisolone
doxorubicin
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
large b-cell lymphoma
chop regimen

Summary

This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with Rituximab, 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.

Details
Condition Lymphoma
Treatment Rituximab, cyclophosphamide, prednisone, Tocilizumab, vincristine, doxorubicin, Glofitamab
Clinical Study IdentifierNCT04980222
SponsorHoffmann-La Roche
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

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, 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
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