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Non-Hodgkin's LymphomaPhase 2NCT00117455

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

A Phase 2 study testing pegfilgrastim and filgrastim in people with Non-Hodgkin's Lymphoma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
pegfilgrastim and filgrastim
How many people
Not given
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

Official title: 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

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.

Keywords
ICE, BEAM, PBPC transplant
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  1. Time to engraftment post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117455
Sponsor's protocol ID
20020113
Status last verified
May 2008
First submitted
30 Jun 2005
Last updated
16 May 2008
Results posted
No

Publications

  • Russell N, Mesters R, Schubert J, Boogaerts M, Johnsen HE, Canizo CD, Baker N, Barker P, Skacel T, Schmitz N. A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy. Haematologica. 2008 Mar;93(3):405-12. doi: 10.3324/haematol.11287. Epub 2008 Feb 11.

    PubMed 18268285

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim and filgrastim in people with Non-Hodgkin's Lymphoma, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequate collection of PBPC's to enable transplant following high dose chemotherapy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00117455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.

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