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A Randomised, Multi-Centre, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Randomised, Multi-Centre, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Non-Hodgkin's Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Adequate collection of PBPC's to enable transplant following high dose chemotherapy

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

20020113

NCT ID:

NCT00117455

Start Date:

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • ICE
  • BEAM
  • PBPC transplant
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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