G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00499343
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Etoposide — DRUG
    150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses.
  • G-CSF — DRUG
    Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
  • GM-CSF — DRUG
    250 mcg/m\^2 injection given every evening till the completion of apheresis.
  • Isophosphamide — DRUG
    10 g/m\^2 given intravenously continuous infusion over 72 hours.
  • Rituximab — DRUG
    Days +1 (375 mg/m\^2) and +8 (1000 mg/m\^2) given intravenously.
  • Apheresis — PROCEDURE
    Peripheral blood stem cell collection.

Study Details

Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging. 2. To determine the incidence of disease progression/relapse at 12 months in the two groups.

Key Dates

Start date
Jan 31, 2004
Status verified
Jun 2013
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
    Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
  • Experimental: Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
    Growth Factor = granulocyte-colony stimulating factor (G-CSF)

Primary Outcome Measure

CD34+ Cells/kg in Blood Stem Cells [ Time Frame: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed. ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

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