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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Glofitamab

    Drug

    human IgG1-bispecific antibody, via IV infusion

  • Polatuzumab

    Drug

    an antibody drug conjugate (ADC) that contains a humanized IgG1 anti-human CD79b monoclonal antibody, via IV infusion

  • Rituximab

    Drug

    Per standard care, via IV infusion

  • Doxorubicin Hydrochloride

    Drug

    Per standard care, via IV infusion

  • Cyclophosphamide

    Drug

    Per standard care, via IV infusion

  • Prednisone

    Drug

    Per standard care, orally

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Polatuzumab + Glofitamab + R-CHExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Complete Response (CR) Rate

The complete response (CR) Rate is the proportion of participants achieving CR based on Lugano criteria defined per protocol section 11.1.1 for target lesions.

Time frame
Baseline through 28 days post Cycle 8 of Glofitamab (each cycle is 21 days)

Secondary outcomes

1

Dose-Limiting Toxicity (DLT)

A DLT will be defined as any of the adverse events (AE) in protocol section 5.4.1 defined toxicities that are determined to be at least possibly related to glofitamab-pola-R-CHP.

Time frame
42 days
2

Grade 3-5 Treatment-related Toxicity Rate

All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.

Time frame
Up to 9 months
3

Overall Response Rate (ORR)

The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on criteria defined per protocol section 11.1.1.

Time frame
8 months
4

Median Duration of Response (DOR)

Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per protocol defined section 11.1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Crombie, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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