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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
bendamustine hydrochloride
Sponsored by
SymBio Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's Lymphoma, Malignant lymphoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2006
Last Updated
October 19, 2020
Sponsor
SymBio Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00389051
Brief Title
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 31, 2006 (Actual)
Primary Completion Date
July 5, 2007 (Actual)
Study Completion Date
October 26, 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SymBio Pharmaceuticals

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Non-Hodgkin's Lymphoma, Malignant lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bendamustine hydrochloride
Intervention Description
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
Primary Outcome Measure Information:
Title
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Secondary Outcome Measure Information:
Title
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Title
Pharmacokinetics profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensei Tobinai, MD, PhD
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
City
Kanagawa
Country
Japan
City
Kyoto
Country
Japan
City
Nagoya
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20594195
Citation
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.
Results Reference
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A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma

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