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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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 facts

Study ID

NCT00499343

Run by

M.D. Anderson Cancer Center

People needed

84

Starts

2004-01-01

Expected to finish

2008-10-01

Last updated by the study team

2013-08-02

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.
• Age up to 70 years
• Platelet count > 100,000 mm3, independent of transfusion support
• Absolute neutrophil count (ANC) > 1500/mm3
• Zubrod performance status of 2 or less.
• Negative pregnancy test in women
• Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies.
• Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody.

You may not qualify if…

• Clinical or radiographic evidence of active CNS disease
• Severe concomitant medical or psychiatric illness
• Lactating or breast feeding females
• Less than 3 weeks from the first day of last chemotherapy
• Prior myeloablative therapy with autologous bone marrow or stem cell rescue
• Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.
• Serum creatinine >1.6 mg/dl
• History of pelvic radiation
• Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)
• Patients should not have received more than 6 cycles of fludarabine therapy

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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