G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Etoposide; G-CSF; GM-CSF; Isophosphamide; Rituximab; Apheresis
Intervention description: 150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.; Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.; 250 mcg/m^2 injection given every evening till the completion of apheresis.; 10 g/m^2 given intravenously continuous infusion over 72 hours.; Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.; Peripheral blood stem cell collection.
Intervention MeSH terms: Rituximab; Etoposide; Ifosfamide; Isophosphamide mustard; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Lymphoma; Etoposide; G-CSF; GM-CSF; Isophosphamide; Rituximab; Ifosfamide; Sargramostim; Leukine; Filgrastim; Neupogen; Apheresis; Stem Cell Collection

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who
             are candidates for autologous stem cell transplantation.

          2. Age up to 70 years

          3. Platelet count > 100,000 mm3, independent of transfusion support

          4. Absolute neutrophil count (ANC) > 1500/mm3

          5. Zubrod performance status of 2 or less.

          6. Negative pregnancy test in women

          7. Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as
             defined by bilateral bone marrow aspirations and biopsies.

          8. Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C
             antibody.

        Exclusion Criteria:

          1. Clinical or radiographic evidence of active CNS disease

          2. Severe concomitant medical or psychiatric illness

          3. Lactating or breast feeding females

          4. Less than 3 weeks from the first day of last chemotherapy

          5. Prior myeloablative therapy with autologous bone marrow or stem cell rescue

          6. Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.

          7. Serum creatinine >1.6 mg/dl

          8. History of pelvic radiation

          9. Patients should not have received more than 3 prior chemotherapy regimens (excluding
             radiation)

         10. Patients should not have received more than 6 cycles of fludarabine therapy