Non-Hodgkin's LymphomaPhase 4NCT02782845
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
A Phase 4 study testing Chemotherapy, Immunochemotherapy and Pegfilgrastim in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 19 sites in 2 countries.
Trial summary
This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Chemotherapy, Immunochemotherapy and Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jun 2006to Oct 2007
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NHL supported by an Immunohistochemical report
- Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2
- Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)
- Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)
Who cannot join
- Bone marrow compromised > 10 percent (%)
- Any malignant myeloid condition
- Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
- Known hypersensitivity reactions to Escherichia coli derived products
- Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Mexico18 sites
Study site
Chihuahua City, 31100
Study site
Chihuahua City, 31240
Study site
Estado de México, 52763
Study site
Guadalajara, 44139
Study site
León, 37320
Study site
León, 37520
Study site
Mexico City, 01120
Study site
Mexico City, 03100
Study site
Mexico City, 06770
Study site
Mexico City, 10700
Study site
Mexico City, 11520
Study site
Mexico City, 31000
Study site
Obregón, 85000
Study site
Puebla City, 72530
Study site
Querétaro, 76000
Study site
Tepic, 63120
Study site
Toluca, 52140
Study site
Veracruz, 91980
About this study
Official title: Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Chemotherapy, Immunochemotherapy, Pegfilgrastim
- 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.
ChemotherapyDrug
The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
ImmunochemotherapyDrug
The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.
PegfilgrastimDrug
Also called Neulastim
Pegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim | Experimental | Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care. Receives: Drug: Chemotherapy; Drug: Immunochemotherapy; Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1
Measured: Cycle 1 (Up to 21 days)
Secondary outcomes (2)
Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6
Measured: Cycles 2 to 6 (Up to 105 days)
Percentage of Participants with Adverse Events
Measured: up to approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782845
- Sponsor's protocol ID
- ML19812
- Status last verified
- Sep 2016
- First submitted
- 16 May 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT02782845
- Acronym / sponsor ID
- ML19812
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 May 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.
This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim | Experimental | Drug: Chemotherapy, Drug: Immunochemotherapy, Drug: PegfilgrastimParticipants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NHL supported by an Immunohistochemical report
- Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2
- Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)
- Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)
Key exclusion criteria (5 listed)
- Bone marrow compromised > 10 percent (%)
- Any malignant myeloid condition
- Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
- Known hypersensitivity reactions to Escherichia coli derived products
- Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method
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 |
|---|---|---|
| ChemotherapyThe choice of CT will be as per standard of care and protocol does not specify any particular CT drug. | Drug | Pegfilgrastim |
| ImmunochemotherapyThe choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug. | Drug | Pegfilgrastim |
| PegfilgrastimAlso: NeulastimPegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles. | Drug | Pegfilgrastim |
Primary outcome
Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1
Time frame: Cycle 1 (Up to 21 days)
2 secondary outcomes
Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6
Time frame: Cycles 2 to 6 (Up to 105 days)
Percentage of Participants with Adverse Events
Time frame: up to approximately 1.5 years
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 21 Nov 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.
Clinical Trials study chair
Hoffmann-La Roche
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chemotherapy, Immunochemotherapy and Pegfilgrastim in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 19 sites in 2 countries.
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 4 inclusion and 5 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Mexico, Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1 (time frame: Cycle 1 (Up to 21 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 21 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.