Hematological NeoplasmsPhase 2NCT00410696
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
A Phase 2 study testing Filgrastim and Pegfilgrastim in people with Hematological Neoplasms and Tumors, run by Armando Santoro, MD at 1 site in Italy.
Trial summary
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Neoplasms, Tumors
- What is being tested?
- Filgrastim and Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2006to Nov 2008
- 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
Who may be able to join
- Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
- Adequate organ function
- Written informed consent.
Who cannot join
- Use of other experimental drugs
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.
Read the detailed description
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.
- Conditions
- Hematological Neoplasms, Tumors
- Being tested
- Filgrastim, Pegfilgrastim
- Keywords
- High-dose chemotherapy, Growth factor, Pegfilgrastim
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Granulokine
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
PegfilgrastimDrug
Also called Neulasta
6 mg/day sc at day +1
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Active comparator | Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days) Receives: Drug: Filgrastim |
| Pegfilgrastim | Experimental | Pegfilgrastim administered the day after autologous stem-cell reinfusion Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of aplasia period
Measured: At time of discharge from Unit
Secondary outcomes (1)
Immunological reconstitution
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematological NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armando Santoro, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Santoro, MD, Istituto Clinico Humanitas
- Investigators
- Armando Santoro, MD, Study director, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410696
- Sponsor's protocol ID
- ONC-2006-001
- Other IDs
- EUDRACT 2006-001409-27
- Status last verified
- Jun 2013
- First submitted
- 12 Dec 2006
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.
PubMed 11821454Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. doi: 10.1038/sj.bmt.1704156.
PubMed 12900776Castagna L, Bramanti S, Levis A, Michieli MG, Anastasia A, Mazza R, Giordano L, Sarina B, Todisco E, Gregorini AI, Santoro A. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.
PubMed 20007996
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial
- ClinicalTrials.gov ID
- NCT00410696
- Acronym / sponsor ID
- ONC-2006-001
- Conditions
- Hematological Neoplasms, Tumors
- Keywords
- High-dose chemotherapy, Growth factor, Pegfilgrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.
Detailed description
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Active comparator | Drug: FilgrastimFilgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days) |
| Pegfilgrastim | Experimental | Drug: PegfilgrastimPegfilgrastim administered the day after autologous stem-cell reinfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
- Adequate organ function
- Written informed consent.
Key exclusion criteria (2 listed)
- Use of other experimental drugs
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgrastimAlso: Granulokine5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution | Drug | Filgrastim |
| PegfilgrastimAlso: Neulasta6 mg/day sc at day +1 | Drug | Pegfilgrastim |
Primary outcome
Duration of aplasia period
Time frame: At time of discharge from Unit
1 secondary outcome
Immunological reconstitution
Time frame: 1 year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
- Background: PubMed 11821454Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.
- Background: PubMed 12900776Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. doi: 10.1038/sj.bmt.1704156.
- Derived from this study: PubMed 20007996Castagna L, Bramanti S, Levis A, Michieli MG, Anastasia A, Mazza R, Giordano L, Sarina B, Todisco E, Gregorini AI, Santoro A. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD study director
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim and Pegfilgrastim in people with Hematological Neoplasms and Tumors, run by Armando Santoro, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Duration of aplasia period (time frame: At time of discharge from Unit). 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 NCT00410696, which also lists 3 linked publications.
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 1 Jul 2013.