Split-Dose R-CHOP for Older Adults With DLBCL

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT03943901
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Cancer
  • DLBCL
  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

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

Study Details

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).

Key Dates

Start date
Feb 17, 2021
Status verified
Jan 2026
Primary completion
Jan 13, 2025
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Split Dose R-CHOP
    Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.

Primary Outcome Measure

Complete Response Rate (CR) [ Time Frame: up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in Madison, WI

By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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