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

NCT ID: NCT00389051

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-10-26

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bendamustine hydrochloride

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

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

SymBio Pharmaceuticals Limited

Principal Investigators

Kensei Tobinai, MD, PhD

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

Kanagawa, , Japan

Kyoto, , Japan

Nagoya, , Japan

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 20594195 (View on PubMed)

Other Identifiers

2006001

Identifier Type: -

Identifier Source: org_study_id