Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01939730
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 by vein once a week for 4 weeks on Days 1, 8, 15, 22.
  • GM-CSF — DRUG
    250 mcg subcutaneously 3 times a week for 8 weeks.

Study Details

The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.

Key Dates

Start date
Aug 31, 1999
Status verified
Nov 2015
Primary completion
Dec 31, 2006
Completion
Sep 30, 2013

Study Design

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

Arms

  • Experimental: Rituximab + GM-CSF
    All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m\^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.

Primary Outcome Measure

Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four) [ Time Frame: 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies