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

Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Peripheral T-Cell Lymphomas, Non-Hodgkin Lymphoma

Thank you

Trial Information

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the dose-limiting toxicity and maximum tolerable dose

Outcome Time Frame:

Phase I

Safety Issue:


Principal Investigator

Won Seog Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

April 2006

Completion Date:

October 2009

Related Keywords:

  • Peripheral T-Cell Lymphomas
  • Non-Hodgkin Lymphoma
  • Velcade
  • Bortezomib
  • CHOP
  • Peripheral T-cell lymphomas(PTCLs)
  • natural killer (NK)-cell lymphomas
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral