Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00193479
Phase
PHASE2
Status
Completed

Conditions

  • Non-Hodgkins Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide
  • Mitoxantrone — DRUG
    Mitoxantrone
  • Vincristine — DRUG
    Vincristine
  • Prednisone — DRUG
    Prednisone
  • Rituximab — DRUG
    Rituximab

Study Details

The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Key Dates

Start date
Apr 30, 2003
Status verified
Feb 2022
Primary completion
Jul 31, 2008
Completion
Feb 28, 2010

Study Design

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

Arms

  • Experimental: Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone
    All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.

Primary Outcome Measure

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists· Fort Myers, FLTennessee Oncology· Nashville, TN

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