Overview

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

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Bayer
Treatments:
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Lenograstim
Mitogens
Rituximab
Sargramostim
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