NCT03487133

Bortezomib/Dexamethasone Therapy in Patients With Relapsed and/or Refractory Cutaneous T-cell Lymphoma

A Prospective, Multi-center, Open-label, Single-arm, Phase II Study of Bortezomib/Dexamethasone Therapy in Patients With Relapsed and/or Refractory Cutaneous T-cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed and/or Refractory Cutaneous T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib/dexamethasone	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

Timeline

• Start date: 2017-09-19
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2018-04-03
• Last updated: 2020-10-26

Locations

1 site across 1 country: South Korea