Randomized, Double-Blind Study Of Peripheral Blood Progenitor Cell (PBPC) Mobilization By Pegfilgrastim Or Filgrastim For Autologous Transplantation In Subjects With Hodgkin's Or Non-Hodgkin's Lymphoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 80,000/mm^3

- No hemolytic anemia or hemoglobinopathy

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- No hepatic cirrhosis

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- 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

Other

- 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
sarcoidosis)

- 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:

Biologic 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

Chemotherapy

- More than 3 weeks since prior myelosuppressive chemotherapy

Endocrine therapy

- More than 14 days since prior corticosteroids

- No concurrent corticosteroids

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- 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