A Study to Evaluate 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

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04980222
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
  • Tocilizumab — DRUG
    Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
  • Doxorubicin — DRUG
    Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
  • Vincristine — DRUG
    Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
  • Prednisone — DRUG
    Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
  • Rituximab — DRUG
    Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
  • Cyclophosphamide — DRUG
    Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.

Study Details

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

Key Dates

First listed
Jul 28, 2021
Start date
Mar 22, 2022
Status verified
Jul 2026
Primary completion
Sep 24, 2024
Completion
Sep 30, 2026

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab + R-CHOP Immunochemotherapy
    Participants will receive step-up doses of glofitamab, starting on Day 8 of Cycle 3 (2.5 mg), Day 15 of Cycle 3 (10 mg), then 30 mg glofitamab will be given every three weeks (Q3W) onwards, on Day 8 of Cycles 4-6 and on Day 1 of Cycles 7-10. (cycle length = 21 days) Participants will receive rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone will be administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)

Primary Outcome Measure

End of Treatment Complete Response (EOT CR) Rate [ Time Frame: Up to approximately 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Stanford Cancer CenterStanfordCalifornia94305-5820-
Stanford Cancer Institute Inpatient Investigational PharmacyStanfordCalifornia94305-
University of IowaIowa CityIowa52242-
University of Michigan Health SystemAnn ArborMichigan48109-
Washington University; Wash Uni. Sch. Of MedSt LouisMissouri63110-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center at WestchesterEast White PlainsNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Baylor University Medical CenterDallasTexas75204-

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By research site
City of Hope Comprehensive Cancer Center· Duarte, CAStanford Cancer Center· Stanford, CAStanford Cancer Institute Inpatient Investigational Pharmacy· Stanford, CAUniversity of Iowa· Iowa City, IAUniversity of Michigan Health System· Ann Arbor, MIWashington University; Wash Uni. Sch. Of Med· St Louis, MO

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