Status:
TERMINATED
An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how well a participant can stand a particular medicine or treatment; ability to be used) of bortezomib in combin...
Detailed Description
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), non-randomized (stu...
Eligibility Criteria
Inclusion
- Participants with histologically confirmed relapsed or refractory follicular Stage III or IV, Grade 1 and 2, cluster of differentiation 20 plus (CD20+) lymphoma (WHO - World Health Organization) that requires therapy
- Participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
- Women must be either postmenopausal or sterilized; negative pregnancy test at Screening
- Participants with total bilirubin below 1.5-fold upper limit of normal (ULN) and creatinine below 2-fold ULN
- Participants with Karnofsky Status greater than or equal to 60 percent
Exclusion
- Participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
- Participants with previous known allergic reaction to bortezomib, boron or mannitol
- Participants with life-expectancy of less than 3 months
- Participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
- Participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (CTCAE) grade greater than or equal to 2
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01902862
Start Date
February 1 2006
End Date
August 1 2007
Last Update
April 1 2014
Active Locations (3)
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1
Kiel, Germany
2
Regensburg, Germany
3
Stuttgart, Germany