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

This study has been completed.
Sponsor:
Information provided by:
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00389051
First received: October 16, 2006
Last updated: August 20, 2007
Last verified: May 2007

October 16, 2006
August 20, 2007
October 2006
Not Provided
  • Hematological toxicity; > grade four (CTCAE v.3.0), during the treatment cycle (twenty one days)
  • Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Same as current
Complete list of historical versions of study NCT00389051 on ClinicalTrials.gov Archive Site
  • All adverse events or adverse reactions, during the treatment cycle (twenty one days)
  • Pharmacokinetics profile
Same as current
Not Provided
Not Provided
 
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-Cell Non-Hodgkin's Lymphoma
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: bendamustine hydrochloride
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2007
Not Provided

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00389051
2006001
Not Provided
Not Provided
SymBio Pharmaceuticals
Not Provided
Study Chair: Kensei Tobinai, MD, PhD National Cancer Center Hospital
SymBio Pharmaceuticals
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP