Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Fort Smith, Arkansas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00101010
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Filgrastim — BIOLOGICAL
    5 mcg/kg, SC daily, start 24 hours after chemotherapy
  • Pegfilgrastim — BIOLOGICAL
    6 mg SC one time (24 hours after chemotherapy)
  • Rituximab — BIOLOGICAL
    375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st
  • Cyclophosphamide — DRUG
    750 mg/m\^2 IVPB on day 1
  • Pegylated liposomal doxorubicin hydrochloride — DRUG
    40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
  • Prednisone — DRUG
    40 mg/m\^2 oral days 1 - 5.
  • Vincristine Sulfate — DRUG
    2 mg IV, day 1

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Key Dates

Start date
Sep 30, 2005
Status verified
Sep 2020
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Rituximab - Combination Chemotherapy
    Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.

Primary Outcome Measure

Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses [ Time Frame: Evaluation after 12 weeks (4 cycles of 21 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFort SmithArkansas72913-
CCOP - Grand RapidsGrand RapidsMichigan49503-
CCOP - KalamazooKalamazooMichigan49007-3731-
Cancer Research for the OzarksSpringfieldMissouri65804-
Hematology Oncology Associates of Central New York, PC - Northeast CenterEast SyracuseNew York13057-4510-
CCOP - Upstate CarolinaSpartanburgSouth Carolina29303-
University of Texas M.D. Anderson CCOP Research BaseHoustonTexas77030-4009-

Find similar trials in Fort Smith, AR

By research site
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center· Fort Smith, ARCCOP - Grand Rapids· Grand Rapids, MICCOP - Kalamazoo· Kalamazoo, MICancer Research for the Ozarks· Springfield, MOHematology Oncology Associates of Central New York, PC - Northeast Center· East Syracuse, NYCCOP - Upstate Carolina· Spartanburg, SC

Related Studies