RATIONALE: Colony-stimulating factors such as filgrastim and pegfilgrastim may increase the
number of peripheral stem cells that can be collected during leukapheresis. Autologous stem
cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and
kill more cancer cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of pegfilgrastim with that
of filgrastim in increasing the number of peripheral stem cells in patients who are
undergoing autologous stem cell transplantation for Hodgkin's lymphoma or non-Hodgkin's
- Compare the CD34+ cells/kg yield from patients receiving single-dose pegfilgrastim (2
different doses) or daily filgrastim (G-CSF) for peripheral blood progenitor cell
(PBPC) mobilization and collection for autologous transplantation in patients with
Hodgkin's or non-Hodgkin's lymphoma.
- Compare the safety of these regimens in these patients.
- Determine the CD34+ cell dynamics and pharmacokinetics of pegfilgrastim in peripheral
blood during the collection phase in these patients.
- Evaluate engraftment of PBPC mobilized by pegfilgrastim in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to amount of prior chemotherapy or radiotherapy (heavily pretreated vs non-heavily
pretreated). Patients are randomized to 1 of 3 treatment arms.
- Peripheral blood progenitor cell (PBPC) mobilization:
- Arm I: Patients receive lower dose pegfilgrastim subcutaneously (SC) on day 1 and
placebo SC on days 1-9.
- Arm II: Patients receive higher dose pegfilgrastim SC on day 1 and placebo SC on
- Arm III: Patients receive filgrastim (G-CSF) SC on days 1-9.
- Leukapheresis: Patients undergo leukapheresis daily, beginning on day 5 until the
desired yield of CD34+ cells is obtained or a maximum of 5 leukaphereses is reached.
- Conditioning: Patients receive a myeloablative chemotherapy regimen as per
- Transplantation of PBPC: Approximately 1-3 days after completion of the conditioning
regimen, patients undergo reinfusion of autologous PBPC. Patients receive G-CSF SC
beginning on day of reinfusion and continuing until blood counts recover.
Patients are followed at 60 and 100 days.
PROJECTED ACCRUAL: A total of 90 patients (30 patients per treatment arm) will be accrued
for this study.
- Histologically confirmed Hodgkin's or non-Hodgkin's lymphoma of any cellular type
- Suitable for peripheral blood progenitor cell (PBPC) mobilization and transplantation
- No CNS primary or metastatic malignancy
- No evidence of myelodysplastic syndromes or sickle cell disease
- 18 and over
- Not specified
- Not specified
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 80,000/mm^3
- No hemolytic anemia or hemoglobinopathy
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- No hepatic cirrhosis
- Creatinine no greater than 1.5 times ULN
- More than 6 months since prior coronary angioplasty
- No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mm Hg)
- No unstable angina
- No New York Heart Association class III or IV congestive heart failure
- No uncontrolled atrial or ventricular cardiac arrhythmias
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other prior malignancy except curatively treated basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix or a surgically cured malignancy
- No significant nonmalignant disease
- No acute or chronic infections (e.g., malaria)
- No inflammatory disease (e.g., Felty's syndrome, systemic lupus erythematosus, or
- No storage diseases (e.g., Gaucher's disease)
- No other concurrent diagnosis that could cause splenomegaly or hypersplenism
- No poorly controlled diabetes
- No known sensitivity to any study products
- No known hypersensitivity to E. coli-derived pharmaceutical products (e.g., G-CSF,
pegfilgrastim, Humulin® insulin, or asparaginase)
PRIOR CONCURRENT THERAPY:
- No prior bone marrow or PBPC transplantation
- More than 1 week since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- WBC must be less than 15,000/mm^3 if growth factor support was administered
concurrently with prior chemotherapy
- No other concurrent G-CSF or GM-CSF
- No other concurrent myeloid stimulating factors
- No concurrent radioimmunotherapy
- More than 3 weeks since prior myelosuppressive chemotherapy
- More than 14 days since prior corticosteroids
- No concurrent corticosteroids
- Not specified
- Not specified
- More than 7 days since prior lithium
- More than 30 days since prior investigational device or drug study
- No concurrent participation in another investigational device or drug study
- No concurrent lithium
- No other concurrent investigational agent