A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389051
• Other study ID #: 2006001
• Status: Completed
• Phase: Phase 1
• Start date: October 31, 2006
• Est. completion date: October 26, 2007

Study information

• Verified date: August 2008
• Source: SymBio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 26, 2007
• Est. primary completion date: July 5, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• bendamustine hydrochloride
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Secondary	All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Secondary	Pharmacokinetics profile