Blood DiseasesNCT02806791
Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment
An observational study of Blood Diseases, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Diseases
- What is being tested?
- FILGRASTIM
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to May 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Blood Cancer
Who may be able to join
- > 18 years with history of autologous transplant
- hematological diseases including:
- Multiple Myeloma
- Hodgkin's Lymphoma
- Non-Hodgkin lymphoma B and T
- Lymphocytic leukemia
- Acute myeloid leukemia
Who cannot join
- N.A.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico
Torino, 10126
About this study
Official title: Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment After Autologous Transplant in Patients With Blood Cancers
The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.
Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.
Read more
For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.
Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.
The study results will not generate any diagnostic or therapeutic intervention in patients still alive.
- Conditions
- Blood Diseases
- Being tested
- FILGRASTIM
- Keywords
- Patients
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FILGRASTIMDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
Measured: until reaching 20,000 platelets (2006-2015)
Trend in blood counts after discharge values
Measured: Until day +75 post autologous transplantation (2006-2015)
Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
Measured: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing)
the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells
Measured: from the first day of chemotherapy mobilizing (2006-2015)
Collection of autologous stem cells (the median number of leukapheresis performed)
Measured: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (median number of white blood cells)
the median number of white blood cells in the process of mobilization
Measured: at the moment of the collection of autologous stem cells
Collection of autologous stem cells ( with the aid of Plerixafor)
the proportion of patients who have the mobilized peripheral blood stem cells with the aid of Plerixafor
Measured: at the moment of the collection of autologous stem cells (2006-2015)
Engraftment after autologous transplantation (granulocyte and platelet engraftment)
cumulative incidence of granulocyte and platelet engraftment
Measured: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation ( median time to achieve neutrophils> 500)
the median time to achieve neutrophils> 500 / ul for 3 consecutive days / platelets> 20,000 / ul for 7 consecutive days
Measured: from transplant to platelets engraftment (2006-2015)
Engraftment after autologous transplantation (the median number of days of G-CSF administration)
Measured: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median number of days of aplasia)
Measured: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median length of stay)
Measured: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (number of transfusions)
number of transfusions of packed red cells and platelet pool / patient needed
Measured: from transplant to platelets engraftment (2006-2015)
Secondary outcomes (2)
transplant-related mortality
Measured: from transplant to death (if applicable) (2006-2015)
Overall survival (overall survival, OS)
Measured: to a year from autologous (2006-2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806791
- Sponsor's protocol ID
- BIO-AUTO 06-15
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment After Autologous Transplant in Patients With Blood Cancers
- ClinicalTrials.gov ID
- NCT02806791
- Acronym / sponsor ID
- BIO-AUTO 06-15
- Conditions
- Blood Diseases
- Keywords
- Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- First posted
- 21 Jun 2016 (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 endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.
Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.
For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.
Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.
The study results will not generate any diagnostic or therapeutic intervention in patients still alive.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Blood Cancer
Key inclusion criteria (7 listed)
- > 18 years with history of autologous transplant
- hematological diseases including:
- Multiple Myeloma
- Hodgkin's Lymphoma
- Non-Hodgkin lymphoma B and T
Key exclusion criteria (1 listed)
- N.A.
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 |
|---|---|---|
| FILGRASTIM | Drug | – |
Primary outcome
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
Time frame: until reaching 20,000 platelets (2006-2015)
Trend in blood counts after discharge values
Time frame: Until day +75 post autologous transplantation (2006-2015)
Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
Time frame: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing)
Time frame: from the first day of chemotherapy mobilizing (2006-2015)
the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells
Collection of autologous stem cells (the median number of leukapheresis performed)
Time frame: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (median number of white blood cells)
Time frame: at the moment of the collection of autologous stem cells
the median number of white blood cells in the process of mobilization
Collection of autologous stem cells ( with the aid of Plerixafor)
Time frame: at the moment of the collection of autologous stem cells (2006-2015)
the proportion of patients who have the mobilized peripheral blood stem cells with the aid of Plerixafor
Engraftment after autologous transplantation (granulocyte and platelet engraftment)
Time frame: from transplant to engraftment (2006-2015)
cumulative incidence of granulocyte and platelet engraftment
Engraftment after autologous transplantation ( median time to achieve neutrophils> 500)
Time frame: from transplant to platelets engraftment (2006-2015)
the median time to achieve neutrophils> 500 / ul for 3 consecutive days / platelets> 20,000 / ul for 7 consecutive days
Engraftment after autologous transplantation (the median number of days of G-CSF administration)
Time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median number of days of aplasia)
Time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median length of stay)
Time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (number of transfusions)
Time frame: from transplant to platelets engraftment (2006-2015)
number of transfusions of packed red cells and platelet pool / patient needed
2 secondary outcomes
transplant-related mortality
Time frame: from transplant to death (if applicable) (2006-2015)
Overall survival (overall survival, OS)
Time frame: to a year from autologous (2006-2015)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Diseases, run by Azienda Ospedaliera San Giovanni Battista 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. 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.
Are results available for this study?
Results are not available in the source record.
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?
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating) (time frame: until reaching 20,000 platelets (2006-2015)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2016.