Status:
COMPLETED
Bortezomib and CHOP in Patients With Advanced Stage Aggressive T Cell or Natural Killer (NK)/T Cell Lymphomas
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Janssen Medical Affairs
Conditions:
Peripheral T-Cell Lymphomas
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Peripheral T-cell lymphomas (PTCLs) are neoplasias from post-thymic T-cells at different stages of differentiation and are a heterogeneous group of malignancies which present with different morphologi...
Eligibility Criteria
Inclusion
- Histologically confirmed PTCLs and NK/T cell lymphomas excluding anaplastic lymphoma kinase (ALK)-positive anaplastic large cell T-cell lymphomas (ALCL)
- Performance status (ECOG) ≤ 3
- Age ≤ 65
- At least one or more unidimensionally measurable lesion(s)
- ≥ 2 cm by conventional computed tomography (CT)
- ≥ 1 cm by spiral CT
- skin lesion (photographs should be taken)
- measurable lesion by physical examination
- Laboratory values
- Creatinine (Cr) \< 1.5 mg% or creatinine clearance (Ccr) \> 50 ml/min
- Transaminase \< 3 X upper normal value
- Bilirubin \< 2.0 mg/dl
- Absolute neutrophil count (ANC) \> 1,500/ul
- Platelets \> 75,000/ul
- Informed consent
- Ann Arbor stage III or IV
Exclusion
- Any other malignancies within the past 5 years except basal cell skin cancer or carcinoma in situ (CIS) of the cervix
- Serious comorbid diseases
- Pregnancy or breast feeding
- Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. This must be documented by both the sponsor and the investigator. No subject will be allowed to enroll in this study more than once.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00374699
Start Date
April 1 2006
End Date
October 1 2009
Last Update
October 14 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, Seoul, South Korea, 135-710