A Phase 1 interventional study of bendamustine hydrochloride in Non-Hodgkin's Lymphoma, sponsored by SymBio Pharmaceuticals. Completed at 4 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by SymBio Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SymBio Pharmaceuticals is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Indolent B cell Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
Exclusion Criteria:Patients who meet any of the following criteria will be excluded.
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Pharmacokinetics profile
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SymBio Pharmaceuticals