Bortezomib/Dexamethasone Therapy in Patients With Relapsed and/or Refractory Cutaneous T-cell Lymphoma
Condition: Relapsed and/or Refractory Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      the efficacy and safety of bortezomib / dexamethasone combination therapy in patients with
      relapsed or refractory T-cell lymphoma who have failed one or more treatments.

        -  primary purpose

           1. Overall response rate

        -  secondary purpose

             1. Progression-free survival and overall survival

             2. Disease stabilization ratio

             3. Duration of reaction

             4. Safety Profile

             5. Experiments on response prediction / immunological markers
    

Detailed description: 
      In a Phase II study in patients with previous T-cell lymphoma, bortezomib was administered at
      a dose of 1.6 mg / m 2 on Day 1 and Day 8, and combined with CHOP (cyclophosphamide,
      doxorubicin, vincristine and prednisolone) chemotherapy . The 1.6 mg / m2 dose of bortezomib
      was obtained through phase 1 studies, and the Phase II study included five patients with skin
      T-cell lymphoma, with an overall response rate of 87%. In addition, there was no significant
      increase in toxicity when bortezomib was administered at 1.6 mg / m2 every week. The fact
      that there was no increase in toxicity in combination with a drug commonly used to induce
      peripheral neuropathy, such as vincristine, / m2 suggests the safety of the dosage at 1 week
      intervals.Therefore, in order to improve the convenience of administration with once-weekly
      dosing, this study combined 1.6 mg / m2 every week for 1 week, 2 weeks, and 3 weeks in a
      4-week cycle, The dose was determined by a single dose.In addition, it is known that the main
      dose-limiting toxicity of subcutaneous injection is significantly reduced in peripheral
      neuropathy, so the route of administration was determined to be via subcutaneous
      administration (18).Considering that one of the major difficulties in remediation of skin
      T-cell lymphoma is the short duration of the response after termination of treatment, the
      subjects who were considered to have a response to the test drug, that is, those who acquired
      a stable lesion response after 8 cycles of induction therapy The test was designed so that
      maintenance therapy can be performed up to one year.Even with one year of maintenance
      therapy, there is no safety concern since the cumulative dose of the test drug is not higher
      than the cumulative dose currently used as the primary treatment for multiple myeloma.
    

Intervention name(s): bortezomib/dexamethasone
Intervention type(s): Drug
Intervention description(s): Induction therapy ->1cycle=28 days 1,2,3week : bortezomib 1.6 mg/m2 SC(subcutaneous), dexamethasone 40mg IV 4week : none maintenance therapy ->1cycle=28 days
1week : bortezomib 1.6 mg/m2 SC(subcutaneous), dexamethasone 40mg IV 2,3,4week : none
Intervention MeSH terms: Dexamethasone; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment