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Non-Hodgkin's LymphomaPhase 2NCT00612183

Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

A Phase 2 study testing bendamustine hydrochloride in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by SymBio Pharmaceuticals at 17 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell lymphoma. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
What is being tested?
bendamustine hydrochloride
Type of treatment
Injection or infusion
How many people
56 participants
Where
17 sitesJapan
Study dates
Dec 2007to Sep 2009
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 or mantle cell lymphoma.
  • Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy.
  • Patients aged from 20 to less than 75 years.
  • Performance Status (P.S.): 0 or 1.
  • Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions).
  • Patients from whom written consent to participate in this study has been obtained.

Who cannot join

  • 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.
Show all 11Show fewer
  • Patients receiving other investigational drugs within 3 months before registration in the study.
  • Patients with allogenic bone-marrow 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • Study site

    Chūō, Tokyo

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Isehara, Kanagawa

  • Study site

    Kagoshima, Kagoshima-ken

  • Study site

    Kashiwa, Chiba

  • Study site

    Koto, Tokyo

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kyoto, Kyoto

  • Study site

    Moriguchi, Osaka

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nagoya, Nagoya

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Shibuya City, Tokyo

  • Study site

    Shinagawa, Tokyo

  • Study site

    Utsunomiya, Tochigi

Other trials in Japan

About this study

Official title: Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)

The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell 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 refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.

Being tested
bendamustine hydrochloride
Keywords
non-Hodgkin's lymphoma, mantle cell lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bendamustine hydrochlorideDrug

    bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]

    Measured: [Treatment period]

Secondary outcomes (1)

  1. CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]

    Measured: [Treatment Period]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612183
Sponsor's protocol ID
2007002
Status last verified
May 2010
First submitted
28 Jan 2008
Last updated
22 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Ohmachi K, Ando K, Ogura M, Uchida T, Itoh K, Kubota N, Ishizawa K, Yamamoto J, Watanabe T, Uike N, Choi I, Terui Y, Usuki K, Nagai H, Uoshima N, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2059-64. doi: 10.1111/j.1349-7006.2010.01635.x.

    PubMed 20626754

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bendamustine hydrochloride in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by SymBio Pharmaceuticals at 17 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 7 inclusion and 11 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas] (time frame: [Treatment period]). 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 NCT00612183, 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 Jul 2010.

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