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Non-Hodgkin's LymphomaPhase 2NCT01118845

Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 study testing SyB L-0501 and Rituximab in people with Non-Hodgkin's Lymphoma and Lymphoma, Large Cell, run by SymBio Pharmaceuticals at 25 sites in 2 countries.

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 determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
SyB L-0501 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
25 sitesin 2 countries
Study dates
Apr 2010to Oct 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
  • Patients with measurable lesions
  • Patients with measurable lesions >1.5 cm in major axes
  • Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
  • Patients who are expected to survive for at least 3 months
  • Patients aged from 20 to 75 years at the time informed consent is obtained
Show all 9Show fewer
  • Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
  • Patients with adequately maintained organ functions
  • Patients capable of personally giving voluntary informed consent in writing to participate in the study

Who cannot join

  • Patients who have been without treatment for less than 3 weeks after prior treatment
  • Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
  • Patients who received adequate prior treatments and did not respond to any of them.
  • Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
  • Patients with serious, active infections
  • Patients with serious complications
Show all 18Show fewer
  • Patients with complications or medical history of serious cardiac disease
  • Patients with serious gastrointestinal symptoms
  • Patients with malignant pleural effusion, cardiac effusion, or ascites retention
  • Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
  • Patients with serious bleeding tendencies
  • Patients with a fever of 38.0°C or higher
  • Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
  • Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ
  • Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
  • Patients who received SyB L-0501 in the past
  • Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study
  • Patients who received other investigational products or unapproved medication within 3 months before registration in this study

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

Japan18 sites

  • Study site

    Akita, Akita

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Hidaka, Saitama

  • Study site

    Isehara, Kanagawa

  • Study site

    Izumo, Shimane

  • Study site

    Kagoshima, Kagoshima-ken

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kita-ku, Okayama-ken

  • Study site

    Kurashiki, Okayama-ken

  • Study site

    Kurume, Fukuoka

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Matsuyama, Ehime

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Ninomaru, Kumamoto

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

Other trials in Japan

South Korea7 sites

  • Study site

    Gangnam-gu, Seoul

  • Study site

    Goyang-si, Gyeonggi-do

  • Study site

    Hwasun-gun, Jeollanam-do

  • Study site

    Jung-gu, Daegu

  • Study site

    Seo-gu, Busan

  • Study site

    Seodaemun-gu, Seoul

  • Study site

    Songpa-gu, Seoul

Other trials in South Korea

About this study

Official title: A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Read the detailed description

Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Being tested
SyB L-0501, Rituximab
Keywords
Non-Hodgkin's lymphoma, Lymphoma, Large B-Cell, Diffuse, Mantle cell lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Medical subject headings
Lymphoma, Non-Hodgkin, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Mantle-Cell, Lymphoma, 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 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.

    SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation.

  • RituximabDrug

    The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.

Study groups in NCT01118845
Study groupRoleWhat they receive
SyB L-0501ExperimentalNot described
Receives: Drug: SyB L-0501; Drug: Rituximab

What is being measured

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

  1. The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma

    CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites.

    For the criteria for CR, See Outcome measure 2 description.

    The criteria for PR is as below.

    Nodal Masses:

    more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes

    1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site
    2. Variably FDG-avid or PET negative; regression on CT

    Spleen, Liver:

    more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen

    Bone Marrow:

    Irrelevant if positive prior to therapy; cell type should be specified

    Measured: up to 30 weeks

Secondary outcomes (15)

  1. The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma

    The criteria for CR is as below

    Nodal Masses:

    1. fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative
    2. Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)

    Spleen, Liver:

    Not palpable, nodules disappeared

    Bone Marrow:

    Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative

    Measured: up to 30 weeks

  2. Progression Free Survival (PFS)

    PFS = day of the first PFS event - day of start of study treatment + 1

    The definitions of PFS event are as below.

    1. PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement
    2. Disease progression during treatment period
    3. Disease progression during follow up period
    4. Start of treatment of new lesion
    5. Occurrence of other multiple malignant tumors
    6. Death

    Measured: up to 30 weeks

  3. Number of Subjects With Adverse Event

    Measured: up to 30 weeks

  4. Number of Adverse Events

    Measured: up to 30 weeks

  5. Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values

    Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).

    grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event

    Measured: up to 30 weeks

  6. Number of Subjects With Grade ≥3 Physical Examination Finding

    Measured: up to 30 weeks

  7. Concomitant Medication Usage

    Measured: up to 30 weeks

  8. The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  9. The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  10. The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  11. The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  12. The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  13. The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  14. The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

  15. The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea

    Measured: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle

Timeline

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

  1. First posted7 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01118845
Sponsor's protocol ID
2010001
Status last verified
May 2013
First submitted
1 May 2010
Last updated
4 Jul 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SyB L-0501 and Rituximab in people with Non-Hodgkin's Lymphoma and Lymphoma, Large Cell, run by SymBio Pharmaceuticals at 25 sites in 2 countries.

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 9 inclusion and 18 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 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Japan, South Korea. 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?

Yes. Results are posted in the registry (first posted 4 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (time frame: up to 30 weeks). 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 NCT01118845.

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 4 Jul 2013.

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