LymphomaPhase 2PALMNCT00794261
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
A Phase 2 study testing Injection of Pegfilgrastim and Injection of Filgrastim in people with Lymphoma and Myeloma, run by Centre Leon Berard at 11 sites in France.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Injection of Pegfilgrastim and Injection of Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesFrance
- Study dates
- Sep 2008to Jun 2010
- 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
- Male or female patients aged ≥ 18 years
- Patients with histologically confirmed lymphoma or myeloma
- Treatment with high-dose chemotherapy before inclusion
- Intensification with high dose Melphalan for patients with myeloma
- Whatever the conditioning regimen, except TBI for patients with 1st relapse of Hodgkin's lymphoma or with MNHL NB: Patients having received two intensification courses are eligible if there has been more than 100 days between courses.
- Autologous PSC transplantation at the time of inclusion
Show all 11Show fewer
- Reinjection of ≥ 2.106 CD34/kg
- Patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (PNN > 0.5 G/L)
- Mandatory affiliation with a health insurance system
- Patients able to understand, read and write French
- Signed, written informed consent
Who cannot join
- TBI during conditioning
- Severe intolerance to the growth factor under study, or hypersensitivity to one of their components
- Immunosuppressive syndrome
- Pregnant or lactating women
- Difficult follow-up
- Documented history of cognitive or psychiatric disorders
- Participation or consideration of participation in another biomedical study during the follow-up period of the present trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Angers
Angers, 49000
CHU Brest
Brest, 29609
Centre Leon Berard
Lyon, 69008
Hopital Edouard Herriot
Lyon, 69008
Hôpital Lapeyronnie
Montpellier, 34295
CHU Nantes
Nantes, 44000
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Henri Becquerel
Rouen, 76038
CHU Toulouse - Hôpital Purpam
Toulouse, 31000
CHU Tours - Hôpital Bretonneau
Tours, 37000
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.
Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.
The number of patients required in this multicentric and prospective study is 150 (13 participating centers).
This is a phase II, controlled, randomized, non comparative and open-label multicentric study.
Read the detailed description
High-dose chemotherapy with autologous peripheral stem cell (PSC) transplantation is a standard consolidation treatment for the initial management of patients with myeloma treated with high-dose Melphalan, or patients with certain lymphomas or with chemosensitive relapses of Hodgkin's lymphoma (HL) or malignant non Hodgkin's lymphoma (MNHL). This procedure is associated with prolonged neutropenia and considerable morbidity. Many randomized trials have tested post-graft administration of granulocyte growth factors (granulocyte colony stimulating Factor: G-CSF) or granulocyte-monocyte growth factors (granulocyte macrophage colony stimulating Factor: GM-CSF). All have shown a reduction of neutropenia and shorter hospital stays on G-CSF or GM-CSF treatment. Different guidelines have recommended the use of growth factors after autologous stem cell transplantation. The effectiveness of growth factor treatment would be identical, whether given immediately after PSC transplantation or delayed until D5 or D7.
Pegfilgrastim is a growth factor resulting from the modification of Filgrastim by addition of a polyethylene glycol (PEG) moiety, which increases its half-life by decreasing its renal clearance. Thus, one injection is equivalent to several Filgrastim injections. Studies of Pegfilgrastim or Filgrastim efficacy on the duration of chemotherapy-induced neutropenia in patients with breast cancer or with non-small cell lung cancer or LMNH have produced equivalent results.
In haematology, Pegfilgrastim has been used for PSC mobilization. Six studies evaluating the efficacy of Pegfilgrastim compared to other G-CSF after autologous hematopoietic PSC transplantation in patients with myeloma and lymphomas have shown equivalent results. A superiority of Pegfilgrastim over other G-CSF has even been reported (though in only one randomized small-scale study).
A randomized phase II study evaluating Pegfilgrastim efficacy and tolerance in lymphoma or myeloma patients receiving PSC transplantation appears necessary to confirm or refute the potential clinical interest of the drug.
On the day of autologous PSC transplantation (D0) the patients will be randomly assigned to receive one or the other treatment strategy.
NB: Patients will receive support care, antibiotic treatments and transfusion procedures specific to each participating centre.
They will be followed-up according to recommendations for the management of this type of patients. No additional examination is planned.
- Being tested
- Injection of Pegfilgrastim, Injection of Filgrastim
- Keywords
- Myeloma, lymphoma, high-dose chemotherapy, PSC infusion, autologous, neutropenia, thrombocytopenia, hospital stay, infection, Autologous PSC transplantation for patients with lymphoma or myeloma treated with high-dose chemotherapy
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell, Neutropenia, Thrombocytopenia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of PegfilgrastimDrug
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
Injection of FilgrastimDrug
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim | Experimental | Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5 Receives: Drug: Injection of Pegfilgrastim |
| Filgrastim | Active comparator | Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L) Receives: Drug: Injection of Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia
Measured: 100 days
Secondary outcomes (6)
Average duration of neutropenia, average duration of thrombocytopenia, number of days with temperature, number of red blood cell units and platelet concentrates transfused to the patient
Measured: 100 days
Average duration of hospital stay since PSC transplantation
Measured: 100 days
Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment
Measured: 100 days
Treatment tolerance
Measured: 100 days
Evaluation of treatment by Filgrastim
Measured: 100 days
Evaluation of treatment costs in the two arms
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Catherine SEBBAN, MD, Principal investigator, Centre Léon Bérard, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794261
- Sponsor's protocol ID
- PALM
- Other IDs
- ET2007 - 113
- Acronym
- PALM
- Status last verified
- Jul 2010
- First submitted
- 19 Nov 2008
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00794261
- Acronym / sponsor ID
- PALM / PALM
- Keywords
- Myeloma, lymphoma, high-dose chemotherapy, PSC infusion, autologous, neutropenia, thrombocytopenia, hospital stay, infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Nov 2008 (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 purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.
Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.
The number of patients required in this multicentric and prospective study is 150 (13 participating centers).
This is a phase II, controlled, randomized, non comparative and open-label multicentric study.
Detailed description
High-dose chemotherapy with autologous peripheral stem cell (PSC) transplantation is a standard consolidation treatment for the initial management of patients with myeloma treated with high-dose Melphalan, or patients with certain lymphomas or with chemosensitive relapses of Hodgkin's lymphoma (HL) or malignant non Hodgkin's lymphoma (MNHL). This procedure is associated with prolonged neutropenia and considerable morbidity. Many randomized trials have tested post-graft administration of granulocyte growth factors (granulocyte colony stimulating Factor: G-CSF) or granulocyte-monocyte growth factors (granulocyte macrophage colony stimulating Factor: GM-CSF). All have shown a reduction of neutropenia and shorter hospital stays on G-CSF or GM-CSF treatment. Different guidelines have recommended the use of growth factors after autologous stem cell transplantation. The effectiveness of growth factor treatment would be identical, whether given immediately after PSC transplantation or delayed until D5 or D7.
Pegfilgrastim is a growth factor resulting from the modification of Filgrastim by addition of a polyethylene glycol (PEG) moiety, which increases its half-life by decreasing its renal clearance. Thus, one injection is equivalent to several Filgrastim injections. Studies of Pegfilgrastim or Filgrastim efficacy on the duration of chemotherapy-induced neutropenia in patients with breast cancer or with non-small cell lung cancer or LMNH have produced equivalent results.
In haematology, Pegfilgrastim has been used for PSC mobilization. Six studies evaluating the efficacy of Pegfilgrastim compared to other G-CSF after autologous hematopoietic PSC transplantation in patients with myeloma and lymphomas have shown equivalent results. A superiority of Pegfilgrastim over other G-CSF has even been reported (though in only one randomized small-scale study).
A randomized phase II study evaluating Pegfilgrastim efficacy and tolerance in lymphoma or myeloma patients receiving PSC transplantation appears necessary to confirm or refute the potential clinical interest of the drug.
On the day of autologous PSC transplantation (D0) the patients will be randomly assigned to receive one or the other treatment strategy.
NB: Patients will receive support care, antibiotic treatments and transfusion procedures specific to each participating centre.
They will be followed-up according to recommendations for the management of this type of patients. No additional examination is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim | Experimental | Drug: Injection of PegfilgrastimSingle subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5 |
| Filgrastim | Active comparator | Drug: Injection of FilgrastimDaily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged ≥ 18 years
- Patients with histologically confirmed lymphoma or myeloma
- Treatment with high-dose chemotherapy before inclusion
- Autologous PSC transplantation at the time of inclusion
- Reinjection of ≥ 2.106 CD34/kg
Key exclusion criteria (7 listed)
- TBI during conditioning
- Severe intolerance to the growth factor under study, or hypersensitivity to one of their components
- Immunosuppressive syndrome
- Pregnant or lactating women
- Difficult follow-up
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 |
|---|---|---|
| Injection of PegfilgrastimSingle subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5 | Drug | Pegfilgrastim |
| Injection of FilgrastimDaily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L) | Drug | Filgrastim |
Primary outcome
Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia
Time frame: 100 days
6 secondary outcomes
Average duration of neutropenia, average duration of thrombocytopenia, number of days with temperature, number of red blood cell units and platelet concentrates transfused to the patient
Time frame: 100 days
Average duration of hospital stay since PSC transplantation
Time frame: 100 days
Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment
Time frame: 100 days
Treatment tolerance
Time frame: 100 days
Evaluation of treatment by Filgrastim
Time frame: 100 days
Evaluation of treatment costs in the two arms
Time frame: 100 days
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 8 Jul 2010.
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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.
Catherine SEBBAN, MD principal investigator
Centre Léon Bérard, Lyon
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of Pegfilgrastim and Injection of Filgrastim in people with Lymphoma and Myeloma, run by Centre Leon Berard at 11 sites in France.
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 11 inclusion and 7 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 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia (time frame: 100 days). 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 8 Jul 2010.