NCT00389051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
14 days until next milestone

Study Start

First participant enrolled

October 31, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2007

Completed
Last Updated

October 22, 2020

Status Verified

August 1, 2008

Enrollment Period

8 months

First QC Date

October 16, 2006

Last Update Submit

October 19, 2020

Conditions

Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's LymphomaMalignant lymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • All adverse events or adverse reactions, during the treatment cycle (twenty one days)

  • Pharmacokinetics profile

Interventions

bendamustine hydrochlorideDRUG

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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 20594195DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kensei Tobinai, MD, PhD

    National Cancer Center Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

October 31, 2006

Primary Completion

July 5, 2007

Study Completion

October 26, 2007

Last Updated

October 22, 2020

Record last verified: 2008-08

Locations

JP(4)