Non-Hodgkin's LymphomaNCT00903812
IMPACT Non Hodgkins Lymphoma (NHL) Study
An observational study of Non-Hodgkin's Lymphoma, run by Amgen.
Trial summary
This is multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- How many people
- 1,837 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects greater than or equal to 18 years old. Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects). Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles) . Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required
Who may be able to join
- Subjects greater than or equal to 18 years old
- Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
- Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
- Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required
Who cannot join
- Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study
About this study
Official title: A Retrospective and Prospective Observational Study Reviewing Supportive Care Management of NHL Patients Treated With CHOP-14 or 21 Chemotherapy(With or Without Rituximab) (CHOP = Cyclophosphamide, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine), Prednisone Chemotherapy )
This is multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
Read the detailed description
This is a multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.
Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- No intervention
- 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.
No interventionOther
No intervention as observational study
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention - observational study Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF
Measured: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903812
- Sponsor's protocol ID
- 20060297
- Status last verified
- Sep 2015
- First submitted
- 14 May 2009
- Last updated
- 6 Jul 2018
- Results posted
- No
Publications
Haioun C, Salar A, Pettengell R, Johnsen HE, Duehrsen U, Rossi FG, Verhoef G, Schwenkglenks M, Jaeger U, Hamilton L, Pujol B, Lugtenburg PJ. Anemia and erythropoiesis-stimulating agent administration in patients with non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisolone +/- rituximab chemotherapy: results from an observational study. Leuk Lymphoma. 2011 May;52(5):796-803. doi: 10.3109/10428194.2011.557166. Epub 2011 Feb 21.
PubMed 21338278Lugtenburg P, Silvestre AS, Rossi FG, Noens L, Krall W, Bendall K, Szabo Z, Jaeger U. Impact of age group on febrile neutropenia risk assessment and management in patients with diffuse large B-cell lymphoma treated with R-CHOP regimens. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):297-305. doi: 10.1016/j.clml.2012.06.004.
PubMed 23040435Pettengell R, Johnsen HE, Lugtenburg PJ, Silvestre AS, Duhrsen U, Rossi FG, Schwenkglenks M, Bendall K, Szabo Z, Jaeger U. Impact of febrile neutropenia on R-CHOP chemotherapy delivery and hospitalizations among patients with diffuse large B-cell lymphoma. Support Care Cancer. 2012 Mar;20(3):647-52. doi: 10.1007/s00520-011-1306-6. Epub 2011 Nov 20.
PubMed 22101611Weycker D, Danel A, Marciniak A, Bendall K, Lipsitz M, Pettengell R. Economic costs of chemotherapy-induced febrile neutropenia among patients with non-Hodgkin's lymphoma in European and Australian clinical practice. BMC Cancer. 2012 Aug 22;12:362. doi: 10.1186/1471-2407-12-362.
PubMed 22913768
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Observational Study Reviewing Supportive Care Management of NHL Patients Treated With CHOP-14 or 21 Chemotherapy(With or Without Rituximab) (CHOP = Cyclophosphamide, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine), Prednisone Chemotherapy )
- ClinicalTrials.gov ID
- NCT00903812
- Acronym / sponsor ID
- 20060297
- Conditions
- Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,837 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 May 2009 (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 is multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
Detailed description
This is a multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.
Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No interventionNo intervention - observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects greater than or equal to 18 years old. Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects). Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles) . Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required
Key inclusion criteria (4 listed)
- Subjects greater than or equal to 18 years old
- Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
- Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
- Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required
Key exclusion criteria (1 listed)
- Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study
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 |
|---|---|---|
| No interventionNo intervention as observational study | Other | A |
Primary outcome
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF
Time frame: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)
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 6 Jul 2018.
- Background: PubMed 21338278Haioun C, Salar A, Pettengell R, Johnsen HE, Duehrsen U, Rossi FG, Verhoef G, Schwenkglenks M, Jaeger U, Hamilton L, Pujol B, Lugtenburg PJ. Anemia and erythropoiesis-stimulating agent administration in patients with non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisolone +/- rituximab chemotherapy: results from an observational study. Leuk Lymphoma. 2011 May;52(5):796-803. doi: 10.3109/10428194.2011.557166. Epub 2011 Feb 21.
- Background: PubMed 23040435Lugtenburg P, Silvestre AS, Rossi FG, Noens L, Krall W, Bendall K, Szabo Z, Jaeger U. Impact of age group on febrile neutropenia risk assessment and management in patients with diffuse large B-cell lymphoma treated with R-CHOP regimens. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):297-305. doi: 10.1016/j.clml.2012.06.004.
- Background: PubMed 22101611Pettengell R, Johnsen HE, Lugtenburg PJ, Silvestre AS, Duhrsen U, Rossi FG, Schwenkglenks M, Bendall K, Szabo Z, Jaeger U. Impact of febrile neutropenia on R-CHOP chemotherapy delivery and hospitalizations among patients with diffuse large B-cell lymphoma. Support Care Cancer. 2012 Mar;20(3):647-52. doi: 10.1007/s00520-011-1306-6. Epub 2011 Nov 20.
- Background: PubMed 22913768Weycker D, Danel A, Marciniak A, Bendall K, Lipsitz M, Pettengell R. Economic costs of chemotherapy-induced febrile neutropenia among patients with non-Hodgkin's lymphoma in European and Australian clinical practice. BMC Cancer. 2012 Aug 22;12:362. doi: 10.1186/1471-2407-12-362.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma, run by Amgen.
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 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: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF (time frame: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)). 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 NCT00903812, which also lists 4 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 6 Jul 2018.