Overview

A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Lenograstim
Criteria
Inclusion Criteria: - Subjects with non-Hodgkin's lymphoma (NHL) who are considered to be
suitable candidates for autologous PBPC transplantation per institution guidelines - ECOG
0-2 inclusive - ANC greater than 1.5 x 10^9/L; PLT greater than 100 x 10^9/L Exclusion
Criteria: - More than one line (regimen) of previous chemotherapy treatment and more than 2
cycles of any premobilisation salvage chemotherapy prior to enrolment. Patients were also
to be excluded from the study if they had received any salvage chemotherapy containing the
following agents: procarbazine, nitrogen mustard, nitrosoureas (including BCNU), melphalan
and fludarabine. - Previous bone marrow or PBPC transplant - Greater than 20% bone marrow
involvement of the disease at time of screening, as demonstrated by biopsy - Prior total
nodal irradiation or any radiotherapy in the past 4 weeks - Serum creatinine greater than
1.5 x upper limit of institutional normal range - Total serum bilirubin greater than 2 x
upper limit of institutional normal range - Current diagnosis of splenomegaly not related
to lymphoma - History of prior malignancy, except for lymphoma, curatively treated basal
cell carcinoma, squamous cell carcinoma, in-situ cervical carcinoma or a surgically cured
malignancy - Any premalignant myeloid condition or any malignancy with myeloid
characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) -
Significant non-malignant disease, including documented HIV infection, uncontrolled
hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive
heart failure (greater than NY Heart Association Class II), poorly controlled diabetes,
coronary angioplasty within 6 months, uncontrolled atrial or ventricular cardiac
arrhythmias, or active hepatitis C - Haematopoietic growth factors administered within 1
week of study entry. If growth factor support was given during previous chemotherapy
cycles, WBC less than 15.0 x 10^9/L was required at enrolment - Treatment with Interferon®
during the last 3 months - Known hypersensitivity to E. coli-derived pharmaceutical
products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase) - Subject had previously been
randomised into this study