02057 - A Randomized Trial of Neulasta (Pegfilgrastim) Versus Neupogen (Filgrastim) to Treat Neutropenia Post-Autologous Peripheral Blood Stem Cell Transplant in Patients with Non-Hodgkin Lymphoma

Principal Investigator: Robert M. Rifkin, MD, FACP

Protocol Number: RMBMT-115

Major Objectives

Patient Selection

Inclusion Criteria:

1. Must be enrolled on USON practice protocol for NHL (BEAC or BEAM – no other high dose regimen is permitted). The site must comply with USOR Protocol 02-021 for the purpose of data collection.
2. Must be scheduled to have an autologous PBSCT for the treatment of NHL; however, patient must not have received an autologous PBSCT prior to the current transplant.
3. Must have ≥ 2.5 × 10⁶ – ≤ 5.0 × 10⁶ CD34+ cells prior to transplant.
4. Has serum creatinine ≤ 2.5 mg/dL and serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
5. Is ≥ 18 years of age.
6. Has no history of primary or metastatic CNS malignancy, seizure disorder, or cerebral vascular accident.
7. Has no history of unstable angina, congestive heart failure (New York Heart Association [NYHA] >Class II or left ventricular ejection fraction (LVEF) <45%), or uncontrolled cardiac arrhythmia.
8. Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential).
9. If of reproductive potential, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for 3 months thereafter.
10. Has signed a Patient Informed Consent Form.

Exclusion Criteria:

1. Has received an allogeneic or autologous peripheral blood stem cell transplant for the treatment of NHL. Note: patient must not have received an autologous PBSCT prior to the current transplant required for this supportive care study.
2. Has received Neulasta or Neupogen within 4 weeks of study entry. Patients can receive a cytokine for mobilization as part of the transplant.
3. Is currently receiving steroid therapy, for any reason other than adrenal insufficiency or that which is disease-related.
4. Is current receiving other chemotherapy or immunotherapy, or hormonal therapy (with the exception of contraceptives or hormone replacement therapy), or any other experimental medications.
5. Is known to be HIV positive.
   Has uncontrolled hypertension (diastolic blood pressure >100 mmHg) on 2 separate measurements at least 7 days apart.
6. Has a history of previous malignancy except non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for >5years.
7. Has gastrointestinal bleeding, hemolysis, or primary hematologic disorder (other than NHL) that could cause anemia.
   Has sickle cell anemia.
8. Has a known hypersensitivity to E. coli-derived or mammalian-derived products or any component of pegfilgrastim or filgrastim.
9. Is a pregnant or nursing woman, or is unwilling to practice an acceptable method of birth control (male and female patients).
10. Is unable to comply with requirements of study.