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

NCT03487133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-10-26

No results posted yet for this study

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

Conditions

  • Relapsed and/or Refractory Cutaneous T-cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Seok Jin Kim · 81, Irwon-Ro, Gangnam-Gu, Seoul, Korea 135-710

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487133 on ClinicalTrials.gov