Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00940342
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • GM-CSF (Sargramostim) — DRUG
    250 mcg injection under the skin, three times a week for eight weeks.
  • Rituximab — DRUG
    375 mg/m\^2 administered intravenously once weekly for four weeks

Study Details

The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.

Key Dates

Start date
Oct 12, 2004
Status verified
Feb 2018
Primary completion
Jan 5, 2017
Completion
Jan 5, 2017

Study Design

Enrollment
130 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treated and Relapsed - Group 1
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
  • Experimental: Treated and High-Risk for Progression - Group 2
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
  • Experimental: 70 Years of Age and Refused Chemo - Group 3
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Blood tests once a week during 8 weeks of treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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