AMD3100-3101 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 μg/kg) Plus G-CSF (10 μg/kg) Versus G-CSF (10 μg/kg) Plus Placebo to Mobilize and Collect ≥ 5x 10⁶ CD34+ Cells/kg in Non-Hodgkin Lymphoma Patients for Autologous Transplantation

Principal Investigator: Peter A. McSweeney, MD

Protocol Number: RMBMT-141

Major Objectives

Patient Selection

Inclusion Criteria:

1. Age 18 to 75 years
2. Diagnosis of NHL
3. Eligible for autologous transplantation
4. In first or second CR or PR
5. &ge 4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of the study)
6. ECOG performance status of 0 or 1
7. Recovered from all acute toxic effects of prior chemotherapy
8. WBC count > 3.0 x 10⁹/l
9. Absolute PMN count > 1.5 x 10⁹/l
10. PLT count > 100 x 10⁹/l
11. Serum creatinine ≤ 2.2 mg/dl
12. SGOT, SGPT, total bilirubin < 2 x upper limit of normal (ULN)
13. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation.
14. Negative for HIV
15. Signed informed consent
16. Patients of childbearing potential agree to use an approved form of contraception.

Exclusion Criteria:

1. A co-morbid condition which, in the view of the investigators,
2. renders the patient at high risk from treatment complications.
3. Prior autologous or allogeneic transplant.
4. Received more than 2 cycles of alkylating agent combinations
5. < 6 weeks off BCNU prior to first dose of G-CSF
6. Received GM-CSF or Neulasta within 3 weeks prior to first dose of G-CSF for mobilization
7. Received prior radio-immunotherapy wuth Zevalin or Bexar
8. Active CNS involvement
9. Active infection requiring antibiotics treatment
10. Fever (temperature > 38 degrees C/ 100.4 degrees F)
11. Positive pregnancy test in female patients
12. Lactating females
13. History of ventricular arrhythmias, including ECG-documented PVCs, during the last 3 years.
14. Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase.
15. Patients whose apheresis product will be further selected and purified.