NCT03943901

Split-Dose R-CHOP for Older Adults With DLBCL

A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating a new administration schedule of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) chemotherapy for participants with Diffuse Large B-Cell Lymphoma (DLBCL), focusing on an underserved elderly population (aged 75 and up; certain participants 70-74 may be eligible) that is often excluded from clinical trials. Participants can expect to be on study for 2.5 years (treatment for 6 months and 2 years of post treatment follow-up).

Detailed description

This study will test the efficacy of split-dose R-CHOP for the treatment of elderly patients with de novo diagnosis of DLBCL or transformed DLBCL. Split-dose R-CHOP involves giving Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy at 14 days' interval with Rituximab given once/month. The safety for every 14-day CHOP administration was studied in a large prospective randomized control trial of patients up to the age of 80 years. In this study, R-CHOP given every 14 days for up to 6 cycles was felt to be the best method of delivery of chemotherapy. Receiving greater than 6 cycles of R-CHOP chemotherapy was not found to be beneficial compared to participants receiving 6 cycles of R-CHOP. Additionally, an interim response adapted approach by combining imaging and MRD testing will be used to identify participants who will receive an abbreviated chemotherapy course if they are both Positron Emission Tomography/Computed Tomography (PET/CT) and Minimum Residual Dose (MRD) negative. In the proposed study, participants will receive a 50% dose reduction of CHOP chemotherapy on Day 1 and Day 15 of each cycle with full dose Rituximab on Day 1 for up to a total of 6 months of chemotherapy. Participants who are MRD and PET/CT negative after 2 months will be placed on an abbreviated regimen with R-CHOP x 4 additional doses with full dose Rituximab and a 50% dose reduction in CHOP chemotherapy. The hypothesis is that this method of administration of R-CHOP will be a safe and effective form of chemotherapy for older patients with DLBCL and will allow older patients to receive curative intent treatment.

Conditions

• Diffuse Large B Cell Lymphoma
• DLBCL
• Cancer

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab is a monoclonal antibody
DRUG	Cyclophosphamide	Chemotherapy drug, alkylating agent
DRUG	Doxorubicin	Chemotherapy drug, anthracycline antibiotic
DRUG	Vincristine	Chemotherapy drug, plant alkaloid
DRUG	Prednisone	Steroid, anti-inflammatory
BIOLOGICAL	Pegfilgrastim	Granulocyte stimulating factor, biologic response modifier

Timeline

• Start date: 2021-02-17
• Primary completion: 2025-01-13
• Completion: 2027-02-01
• First posted: 2019-05-09
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study