LymphomaPhase 3NCT02238873
Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma
A Phase 3 study testing Pegfilgrastim in people with Lymphoma and Neutropenia, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lymphoma, Neutropenia
- What is being tested?
- Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Jan 2018
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18 years or above)
- Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's lymphoma
- Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP). Chemotherapy dose reduction will be allowed.
- Chemotherapy with or without immunotherapy
- Therapy in hospital or at the outpatient clinic
Who cannot join
- Indolent lymphoma; we will exclude patients with transformed lymphoma.
- Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).
- Uncontrolled infection
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, 49100
Liat Vidal, MD, 972-50-4065313, vidallit@yahoo.com
About this study
Official title: Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial
Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. It has a much longer half-life than the parent filgrastim. It is removed from the body within the neutrophils. According to the American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is cleared before and after neutropenia. Comparative low quality studies suggest that deferring pegfilgrastim delivery until neutrophil counts start dropping may result in improved its efficacy. This was further tested in a few small randomized controlled trials (high quality studies, considered the "gold standard" of studies) in different settings (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia, neutrophil count, length of hospitalization, mortality, and safety.
- Conditions
- Lymphoma, Neutropenia
- Being tested
- Pegfilgrastim
- Keywords
- lymphoma, neutropenia, pegfilgrastim
- Medical subject headings
- Lymphoma, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
Also called Neulastim
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim +1 | Active comparator | Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy Receives: Drug: Pegfilgrastim |
| Pegfilgrastim +3 | Experimental | Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Febrile neutropenia
Number of participants with fever and neutropenia
Measured: 30 days
Neutrophil count <500/ mcL
Number of participants with neutrophil count below 500 /mcL
Measured: day 8 to 10
Secondary outcomes (6)
Mortality
Number of participants who died by day 30
Measured: 30 days
Neutrophil count <100/ mcL
Number of patients with neutrophil count below 100/ mcL
Measured: day 8 to 10
Number of febrile days
a febrile day defined by at least one documented temperature measurement >38ºC
Measured: 30 days
Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization
Number of participants with CDI, MCI or BSI. CDI, MDI and BSI will be defined in accordance with the CDC surveillance definitions for healthcare-associated infections
Measured: 30 days
Hospitalization
Number of hospitalization days of each participant (excluding days of hospitalization for chemotherapy)
Measured: 30 days
Adverse events
ECOG common toxicity criteria grading Number of patients with an adverse event (AE). Number of patients with grade 3-4 AE
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2018 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center, Soroka University Medical Center
- Responsible party
- Principal investigator, LIAT VIDAL FISHER, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238873
- Sponsor's protocol ID
- PEGFIL
- Status last verified
- Oct 2014
- First submitted
- 8 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02238873
- Acronym / sponsor ID
- PEGFIL
- Conditions
- Lymphoma, Neutropenia
- Keywords
- lymphoma, neutropenia, pegfilgrastim
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center, Soroka University Medical Center
- Study start
- Oct 2014
- Primary completion
- Jan 2018 (estimated)
- First posted
- 12 Sep 2014 (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.
Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. It has a much longer half-life than the parent filgrastim. It is removed from the body within the neutrophils. According to the American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is cleared before and after neutropenia. Comparative low quality studies suggest that deferring pegfilgrastim delivery until neutrophil counts start dropping may result in improved its efficacy. This was further tested in a few small randomized controlled trials (high quality studies, considered the "gold standard" of studies) in different settings (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia, neutrophil count, length of hospitalization, mortality, and safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim +1 | Active comparator | Drug: PegfilgrastimPegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy |
| Pegfilgrastim +3 | Experimental | Drug: PegfilgrastimPegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (age 18 years or above)
- Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's lymphoma
- Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP). Chemotherapy dose reduction will be allowed.
- Chemotherapy with or without immunotherapy
- Therapy in hospital or at the outpatient clinic
Key exclusion criteria (4 listed)
- Indolent lymphoma; we will exclude patients with transformed lymphoma.
- Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).
- Uncontrolled infection
- Pregnant women
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 |
|---|---|---|
| PegfilgrastimAlso: Neulastim | Drug | Pegfilgrastim +1, Pegfilgrastim +3 |
Primary outcome
Febrile neutropenia
Time frame: 30 days
Number of participants with fever and neutropenia
Neutrophil count <500/ mcL
Time frame: day 8 to 10
Number of participants with neutrophil count below 500 /mcL
6 secondary outcomes
Mortality
Time frame: 30 days
Neutrophil count <100/ mcL
Time frame: day 8 to 10
Number of febrile days
Time frame: 30 days
Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization
Time frame: 30 days
Hospitalization
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegfilgrastim in people with Lymphoma and Neutropenia, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 4 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 2 Oct 2014. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Liat Vidal-Fisher, MD (972-50-4065313, vidallit@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Febrile neutropenia (time frame: 30 days). The study lists 2 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 2 Oct 2014.