A Phase I Study of Bendamustine Hydrochloride in Patients... | NCT00389051

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

NCT00389051

Sponsor

SymBio Pharmaceuticals

Status

Completed

Last Update Posted

Oct 22, 2020Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Interventions

bendamustine hydrochloride

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2006Actual

Primary Completion Date

Jul 5, 2007Actual

Completion Date

Oct 26, 2007Actual

First Submitted Date

Oct 16, 2006

First Submission Date that Met QC Criteria

Oct 16, 2006

First Posted Date

Oct 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2020

Last Update Posted Date

Oct 22, 2020Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Name	Type	Description	Arm Group Labels	Other Names
bendamustine hydrochloride	Drug	1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)

Measure	Description	Time Frame
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kensei Tobinai, MD, PhD	National Cancer Center Hospital	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20594195	Derived	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.

Facility	Status	City	State	ZIP	Country	Contacts
		Kanagawa			Japan

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Measure	Description	Time Frame
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Pharmacokinetics profile