Clinical trial NCT00389051: A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma
Malignant lymphoma
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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.

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.

Primary outcomes:
measure: Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Secondary outcomes:
measure: All adverse events or adverse reactions, during the treatment cycle (twenty one days)
measure: Pharmacokinetics profile
Other outcomes:
Locations:
city: Kanagawa
country: Japan
city: Kyoto
country: Japan
city: Nagoya
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.