A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Part of paid clinical trials in Rochester, New York.

Sponsor
Patrick Reagan
Study ID
NCT02734771
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Brentuximab vedotin — DRUG
  • Rituximab — DRUG
  • Cyclophosphamide — DRUG
  • Doxorubicin — DRUG
  • Prednisone — DRUG

Study Details

This is a study incorporating brentuximab vedotin and dose attenuated rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the overlapping toxicities with brentuximab vedotin.

Key Dates

Start date
Jun 30, 2016
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: BV+mini-R-CHP
    Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles

Primary Outcome Measure

Percent of Subjects Completing Regimen [ Time Frame: 20 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
James P. Wilmot Cancer Institute, University of Rochester Medical CenterRochesterNew York14642-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

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