Non-Hodgkin's LymphomaPhase 1NCT00794638
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing SyB L-0501 and Rituximab in people with Non-Hodgkin's Lymphoma and Diffuse Large B-Cell Lymphoma, run by SymBio Pharmaceuticals at 4 sites in Japan.
Trial summary
The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- SyB L-0501 and Rituximab
- How many people
- 9 participants
- Where
- 4 sitesJapan
- Study dates
- Nov 2008to May 2010
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:
- Diffuse large B-cell lymphoma
- Mantle cell lymphoma
- Transformed lymphoma
- Follicular lymphoma (Grade 3)
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- Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
- Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
- Patients aged from 20 to 75 years at the time informed consent is obtained
- Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
- Patients who can be hospitalized during the first cycle
- Patients capable of personally giving voluntary informed consent in writing to participate in the study
Who cannot join
- Patients who meet any of the following criteria will be excluded.
- Patients with serious complications (hepatic or renal failure)
- Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- Patients positive for HBs antigen, HCV antibody, or HIV antibody
- Patients who received other investigational drug or unapproved medication within 3 months before registration in this study
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- Patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
- Patients who are pregnant, of childbearing potential, or lactating
- Patients, whether male or female, who do not agree to contraception
- Patients otherwise judged by investigator or sub investigator to be unsuitable
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Chuo-ku, Tokyo
Study site
Isehara, Kanagawa
Study site
Kyoto, Kyoto
Study site
Nagoya, Aichi-ken
About this study
Official title: A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.
- Conditions
- Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Being tested
- SyB L-0501, Rituximab
- Keywords
- Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle cell Lymphoma, Transformed lymphoma, transformed to diffuse large B-cell lymphoma, Follicular Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyB L-0501Drug
Also called Bendamustine hydrochloride
The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
RituximabDrug
The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: Treatment period
Secondary outcomes (1)
CR rate and the overall response rate, determination by Independent Review Committee
Measured: Treatment period
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 startNov 2008
- Primary completionMar 2010
- Study completionMay 2010
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kensei Tobinai, MD, Ph D, Study chair, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794638
- Sponsor's protocol ID
- 2008002
- Status last verified
- Jul 2021
- First submitted
- 18 Nov 2008
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00794638
- Acronym / sponsor ID
- 2008002
- Conditions
- Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle cell Lymphoma, Transformed lymphoma, transformed to diffuse large B-cell lymphoma, Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 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 assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:
- Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
- Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
- Patients aged from 20 to 75 years at the time informed consent is obtained
Key exclusion criteria (10 listed)
- Patients who meet any of the following criteria will be excluded.
- Patients with serious complications (hepatic or renal failure)
- Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- Patients positive for HBs antigen, HCV antibody, or HIV antibody
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 |
|---|---|---|
| SyB L-0501Also: Bendamustine hydrochlorideThe administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation). | Drug | – |
| RituximabThe administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation). | Drug | – |
Primary outcome
Dose-limiting toxicity
Time frame: Treatment period
1 secondary outcome
CR rate and the overall response rate, determination by Independent Review Committee
Time frame: Treatment period
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 2 Jul 2021.
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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.
Kensei Tobinai, MD, Ph D study chair
National Cancer Center Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SyB L-0501 and Rituximab in people with Non-Hodgkin's Lymphoma and Diffuse Large B-Cell Lymphoma, run by SymBio Pharmaceuticals at 4 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 12 inclusion and 10 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dose-limiting toxicity (time frame: Treatment period). 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 Jul 2021.