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

Sponsor
SymBio Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00389051
Collaborator
(none)
9
Enrollment
4
Locations
11.8
Actual Duration (Months)
2.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: bendamustine hydrochloride
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 31, 2006
Actual Primary Completion Date :
Jul 5, 2007
Actual Study Completion Date :
Oct 26, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. All adverse events or adverse reactions, during the treatment cycle (twenty one days) []

  2. Pharmacokinetics profile []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanagawa Japan
2 Kyoto Japan
3 Nagoya Japan
4 Tokyo Japan

Sponsors and Collaborators

  • SymBio Pharmaceuticals

Investigators

  • Study Chair: Kensei Tobinai, MD, PhD, National Cancer Center Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00389051
Other Study ID Numbers:
  • 2006001
First Posted:
Oct 17, 2006
Last Update Posted:
Oct 22, 2020
Last Verified:
Aug 1, 2008
Keywords provided by , ,
Non-Hodgkin's Lymphoma
Malignant lymphoma
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Bendamustine Hydrochloride

Study Results

No Results Posted as of Oct 22, 2020