Health Trials

A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma

ConditionsLymphomaLymphoma, Large B-Cell, Diffuse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Crombie, MD

About this trial

The goal of this research study is to evaluate the combination of study drugs, Glofitamab and Polatuzumab, and a standard chemotherapy regimen, R-CHP, as a treatment for high-risk diffuse large B-cell lymphoma.

The names of the treatment interventions involved in this study are:

* Glofitamab (T-cell bispecific antibody) * Polatuzumab (antibody-drug conjugate) * R-CHP (a chemotherapy regimen comprised of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, and Prednisone)

Eligibility criteria

Qualifiers

Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms

DLBCL, not otherwise specified (NOS)

T-cell/histiocyte-rich large B-cell lymphoma

Epstein-Barr virus-positive DLBCL, NOS

Disqualifiers

Contraindication to any of the individual components of study drugs, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products. Patients with a history of hypersensitivity to dexamethasone or systemic corticosteroids will also be excluded

Prior organ transplantation

History of indolent lymphoma or current diagnosis of the following: follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; CNS lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL

Palliative, short-term treatment with corticosteroids (up to 7 days).

Trial design

Treatments tested in this trial

  • Glofitamab
  • Polatuzumab
  • Rituximab
  • Doxorubicin Hydrochloride
  • Cyclophosphamide
  • Prednisone

Treatment groups

41 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jennifer Crombie, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov