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

Part of paid clinical trials in Miami, Florida.

Sponsor
Jennifer Crombie, MD
Study ID
NCT05800366
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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)

Key Dates

Start date
Apr 6, 2023
Status verified
Mar 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2029

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab + Glofitamab + R-CH
    -Participants will receive treatment interventions as outlined: Experimental: Safety Lead-In Phase of 6 Participants, Total Enrollment of 40 Participants * Polatuzumab, once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6 * R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone * Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6: * Prednisone) 5 days, predetermined day and dosage per cycle, per protocol Cycles 1 - 6: * Glofitamab * twice, predetermined day and dosage per cycle, per protocol Cycle 3-6 * once, predetermined day and dosage per cycle, per protocol Cycle 7-8 * Participants who need urgent therapy are also allowed to proceed with one cycle of R-CHOP for 1 cycle per standard of care. * Participants will be followed for up to 5 years post-treatment.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Baseline through 28 days post Cycle 8 of Glofitamab (each cycle is 21 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Cancer CenterMiamiFlorida33136
Juan Alderuccio, MD
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Clare Phinney
[email protected]
Gottfried von Keudell, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Jennifer Crombie, MD
Clare Phinney
[email protected]
Jennifer Crombie, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Cancer Center· Miami, FLBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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