|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00139841 |
|
Date of registration:
|
18/08/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
|
|
Scientific title:
|
A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab |
|
Date of first enrolment:
|
October 2005 |
|
Target sample size:
|
103 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00139841 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
|
Puerto Rico
|
United States
| | | | | |
|
Key inclusion & exclusion criteria
|
ELIGIBILITY:
Key Inclusion Criteria
- Documented B-cell Non-Hodgkin's Lymphoma
- Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)
- Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
- Lymphoplasmacytic lymphoma
- Follicular center lymphoma, follicular
Disease documented to be refractory to a full-course of the most recent rituximab therapy
(single agent or combination)
- At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
- Bidimensionally measurable disease (by CT scan) with at least one lesion measuring =
2.0 cm in a single dimension
Key Exclusion Criteria
- Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan
(Zevalin®) will not be eligible
- History of prior high dose chemotherapy with allogeneic stem cell support (history of
autologous stem cell support is permissible)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Non-Hodgkin's Lymphoma
|
|
Intervention(s)
|
|
Drug: Bendamustine HCl
|
|
Primary Outcome(s)
|
|
Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy.
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
SDX-105-03
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|