NeutropeniaPhase 2NCT00364468
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
A Phase 2 study testing pegfilgrastim in people with Neutropenia, run by Kyowa Kirin Co., Ltd. at 6 sites in Japan.
Trial summary
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Neutropenia
- What is being tested?
- pegfilgrastim
- How many people
- 107 participants
- Where
- 6 sitesJapan
- Study dates
- Mar 2006to Mar 2008
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed as malignant lymphoma
- patients who were refractory to anthracycline or anthraquinone containing chemotherapy
- patients who are going to receive ESHAP or CHASE treatment regimen
- ECOG performance status =< 2
- patients who have appropriate bone marrow, hepatic and renal functions
- written informed consent
Who cannot join
- double cancer
- history of bone marrow transplantation or PBSCT
- more than 2 prior chemotherapy regimens
- primary hematologic disease such as myelodysplastic syndrome
- previous radiotherapy within 4 weeks of enrollment
- woman of childbearing potential who were either pregnant, breast feeding
- patients who participated in other clinical trials within the last 4 weeks of enrollment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Tokai region
Aichi
Kyusyu region
Fukuoka, Nagasaki
Kanto region
Gunma, Saitama, Tokyo, Kanagawa
Hokkaido region
Hokkaido
Kinki region
Kyoto, Mie, Shiga
Tohoku region
Miyagi
About this study
Official title: A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
- Conditions
- Neutropenia
- Being tested
- pegfilgrastim
- Keywords
- pegfilgrastim, neutropenia, cancer patients, lymphoma
- Medical subject headings
- Neutropenia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the duration of severe neutropenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomomitsu Hotta, MD, Study chair, Nagoya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364468
- Sponsor's protocol ID
- KRN125/05-A04
- Status last verified
- Feb 2017
- First submitted
- 14 Aug 2006
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT00364468
- Acronym / sponsor ID
- KRN125/05-A04
- Conditions
- Neutropenia
- Keywords
- pegfilgrastim, neutropenia, cancer patients, lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Aug 2006 (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.
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients diagnosed as malignant lymphoma
- patients who were refractory to anthracycline or anthraquinone containing chemotherapy
- patients who are going to receive ESHAP or CHASE treatment regimen
- ECOG performance status =< 2
- patients who have appropriate bone marrow, hepatic and renal functions
Key exclusion criteria (7 listed)
- double cancer
- history of bone marrow transplantation or PBSCT
- more than 2 prior chemotherapy regimens
- primary hematologic disease such as myelodysplastic syndrome
- previous radiotherapy within 4 weeks of enrollment
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 |
|---|---|---|
| pegfilgrastim | Drug | – |
Primary outcome
To compare the duration of severe neutropenia
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 3 Mar 2017.
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Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
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A Study to Investigate the Safety and Tolerability of Granulocyte-colony Stimulating Factor (G-CSF) Dosage Reduction in Mavorixafor-treated Participants With Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders
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Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
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.
Tomomitsu Hotta, MD study chair
Nagoya Medical Center
6 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 pegfilgrastim in people with Neutropenia, run by Kyowa Kirin Co., Ltd. at 6 sites in Japan.
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 6 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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?
To compare the duration of severe neutropenia. 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 3 Mar 2017.