Non-Hodgkin's LymphomaPhase 1NCT00389051
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing bendamustine hydrochloride in people with Non-Hodgkin's Lymphoma, run by SymBio Pharmaceuticals at 4 sites in Japan.
Trial summary
The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- bendamustine hydrochloride
- How many people
- 9 participants
- Where
- 4 sitesJapan
- Study dates
- 31 Oct 2006to 26 Oct 2007
- 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
- Indolent B cell Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma.
- Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
- Patients aged from 20 to less than 75 years.
- Patients who had agreed in-patient during first course therapy.
- Patients from whom written consent to participate in this study has been obtained.
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- Exclusion Criteria:Patients who meet any of the following criteria will be excluded.
- Patients with apparent infections.
- Patients with serious complications (hepatic failure or renal failure).
- Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
- Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
- Patients who are known to be positive for HBV, HCV or HIC.
- Patients receiving other investigational drugs within 3 months before registration in the study.
- Patients with allogenic transplant.
- Women who are pregnant, of childbearing potential, or lactating.
- Patients who do not agree to contraception.
- Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Kanagawa
Study site
Kyoto
Study site
Nagoya
Study site
Tokyo
About this study
Official title: A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma
The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.
Read the detailed description
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with indolent B-cell Non-hodgkin's lymphoma.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- bendamustine hydrochloride
- Keywords
- Non-Hodgkin's Lymphoma, Malignant lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine hydrochlorideDrug
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Secondary outcomes (2)
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Pharmacokinetics profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study start31 Oct 2006
- Primary completion5 Jul 2007
- Study completion26 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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)
- Investigators
- Kensei Tobinai, MD, PhD, Study chair, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389051
- Sponsor's protocol ID
- 2006001
- Status last verified
- Aug 2008
- First submitted
- 16 Oct 2006
- Last updated
- 22 Oct 2020
- Results posted
- No
Publications
Ogura M, Uchida T, Taniwaki M, Ando K, Watanabe T, Kasai M, Matsumoto Y, Shimizu D, Ogawa Y, Ohmachi K, Yokoyama H, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Phase I and pharmacokinetic study of bendamustine hydrochloride in relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2054-8. doi: 10.1111/j.1349-7006.2010.01633.x.
PubMed 20594195
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00389051
- Acronym / sponsor ID
- 2006001
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Malignant lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2006 (actual)
- Primary completion
- 5 Jul 2007 (actual)
- Study completion
- 26 Oct 2007 (actual)
- First posted
- 17 Oct 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.
The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.
Detailed description
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with indolent B-cell Non-hodgkin's lymphoma.
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 (17 listed)
- Indolent B cell Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma.
- Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
- Patients aged from 20 to less than 75 years.
- Patients who had agreed in-patient during first course therapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| bendamustine hydrochloride1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles) | Drug | – |
Primary outcome
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
2 secondary outcomes
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Pharmacokinetics profile
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 22 Oct 2020.
- Derived from this study: PubMed 20594195Ogura M, Uchida T, Taniwaki M, Ando K, Watanabe T, Kasai M, Matsumoto Y, Shimizu D, Ogawa Y, Ohmachi K, Yokoyama H, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Phase I and pharmacokinetic study of bendamustine hydrochloride in relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2054-8. doi: 10.1111/j.1349-7006.2010.01633.x.
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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, PhD 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 bendamustine hydrochloride in people with Non-Hodgkin's 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 17 inclusion and 0 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 22 Oct 2020. 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?
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days). 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 NCT00389051, which also lists 1 linked publication.
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 22 Oct 2020.