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TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

ConditionsDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaLymphomaLymphoma, B-Cell
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University

About this trial

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.

Age ≥18 years.

Diffuse large B-cell lymphoma, not otherwise specified (NOS)

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

Disqualifiers

Pregnancy, breast-feeding, or prisoner status.

Central nervous system involvement by the lymphoma.

Prior solid organ transplantation or allogeneic stem cell transplantation.

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tafasitamab

    Drug

    Cytolytic monoclonal antibody targeting CD19.

  • Polatuzumab vedotin

    Drug

    CD79b-targeting antibody-drug conjugate

  • Glofitamab

    Drug

    CD20xCD3 bispecific antibody

  • Obinutuzumab

    Drug

    Anti-CD20 monoclonal antibody

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TPG therapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete response rate

• Complete response (CR) rate after 4 cycles of TPG therapy, evaluated by PET-CT using Lugano criteria

Time frame
3 months after starting therapy
2

Rate of toxicities

Occurrence and severity of adverse events will be examined throughout the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0, except cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be assessed using the American Society of Transplantation and Cellular Therapy (ASTCT) criteria

Time frame
From the day when informed consent is obtained until 90 days following the last administration of study treatment.

Secondary outcomes

1

Progression-free survival

PFS will be determined according to the guidance from the International Working Group

Time frame
PFS will be measured from the day of the registration on study until the end of follow up, for up to 5 years
2

Event-free survival

EFS will be determined using the following events: disease progression, disease recurrence, a switch from TPG to standard chemotherapy (or alternative therapy), initiation of any new therapy for lymphoma after attaining a CR, or death from any cause.

Time frame
EFS will be measured from the day of the registration on study until the end of follow up, for up to 5 years
3

Overall survival

OS will be determined using death from any cause and measured from registration until the end of follow up.

Time frame
OS will be measured from the day of the registration on study until the end of follow up, for up to 5 years
4

Duration of response

assessed only for patients who achieve an overall response

Time frame
Duration of response will be measured from the day of the first response recored on study until the end of follow up, for up to 5 years

Other outcomes

Sponsors and contacts

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

Brown University

Lead sponsor

Incyte Corporation

Collaborator

Genentech, Inc.

Collaborator

Natera, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: