A Phase I/II Study of Bortezomib + CHOP in Patients With Advanced Stage Aggressive T Cell or NK/T Cell Lymphomas
Inclusion Criteria:
- 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 Criteria:
- 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.