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

NCT03487133 | Completed Phase 2 DMC

• 1 other identifier: 2017-02-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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
• Progression-free survival and overall survival
• Disease stabilization ratio
• Duration of reaction
• Safety Profile
• Experiments on response prediction / immunological markers

Conditions

Relapsed and/or Refractory Cutaneous T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate of tumor

  Overall response rate (complete remission, partial remission) according to the ISCL-USCLC-EORTC recommendation evaluated by institutional investigators

  Through study completion, an average of 3 years

Secondary Outcomes (3)

• progressive-free survival

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months

• Disease stabilization rate

  An average of 6 years

• Duration of response

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months

Study Arms (1)

bortezomib/dexamethasone

EXPERIMENTAL

Subjects who have been diagnosed with stable lesions more than 4 cycles of induction therapy (Induction Therapy Part I) will receive additional induction therapy 4 cycles (Induction Therapy Part II) Patients who have been diagnosed with a stable disease response after a total of eight cycles of induction therapy receive up to one year of maintenance therapy.

Drug: bortezomib/dexamethasone

Interventions

bortezomib/dexamethasone DRUG

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

bortezomib/dexamethasone

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed subcutaneous skin T-cell lymphoma based on the WHO(World Health Organization)-EORTC classification (mycosis fungoides, Sezary syndrome,primary cutaneous anaplastic large cell lymphoma,lymphomatoid papulosis,primary cutaneous peripheral T-cell lymphoma, unspecified)
• Male and female patients aged 19-80
• ECOG(Eastern Cooperative Oncology Group performance) 0\~2
• Presence of measurable lesion according to ISCL(International Society for Cutaneous Lymphomas)-USCLC(United States Cutaneous Lymphoma Consortium)-EORTC(European Organization of Research and Treatment of Cancer) recommendation
• If one or more of the previous treatments fails or has recurred / progressed
• Proper function status of bone marrow, kidney, liver
• All toxic effects due to previous treatment have been resolved to CTCAE 4.03 version 1 or lower
• For pregnant women, the result of pregnancy test is negative. (The pregnant female patient should have effective contraception during the treatment period and for one month thereafter) (ie, hormonal contraceptive device, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) Men should use effective contraception during the treatment period and for three months thereafter.)
• Patients who are expected to follow and comply with the clinical trial protocol at the discretion of the tester
• Patients who voluntarily agreed to participate in this trial and signed a consent form
• Patients who agreed to donate a sample of peripheral lesions (10 unstained slides) and 3 ml of peripheral blood after baseline and cycle 8

You may not qualify if:

• Patients undergoing chemotherapy at the time of clinical trials
• Patients who are undergoing radiotherapy at the time of their participation in the trial or who received radiotherapy within the first 6 months of the trial. However, patients who have additional lesions elsewhere in the main lesion may be eligible for clinical trials if they have completed local radiotherapy as a palliative treatment prior to the administration of the drug, and recovered from the resulting toxicity.
• Patients with symptomatic or uncontrolled angina and congestive heart failure, arrhythmia requiring drug therapy, significant risk of clinically significant myocardial infarction within 6 months prior to participation in this trial
• Patients with stable left ventricular ejection fraction less than the normal lower limit of each organ.
• Adverse Reactions Common Terminology Criteria 4.03 In case of infection in excess of grade 2 according to the standards. Hepatitis B is allowed if there is no active replication (HBV DNA\> 20,000 iU / mL associated with ALT(alanine aminotransferase) exceeding twice the normal upper limit).
• If there is active infection, including severe concomitant disease and / or active hepatitis C and human immunodeficiency virus infection
• Patients who received chemotherapy, surgical treatment (permissive for mild surgical treatment) within 4 weeks of the administration of this drug
• History of allogeneic transplantation (including hematopoietic stem cell transplantation)
• Patients with a malignant tumor other than the target disease. However, the following cases are allowed.If you have not received treatment for the tumor for at least 5 years or have no disease,Complete resection of basal cell carcinoma / squamous cell carcinoma or at least 1 year after successful treatment of cervical intraepithelial cancer
• Adverse reactions within 30 days prior to the start of screening Common Grade Criteria 4.03 Severe gastrointestinal bleeding in excess of grade 2
• The occurrence of thrombosis or embolism within 6 months before screening
• Patients with central nervous system involvement.
• Pregnant, lactating, or reproductive women who are not willing to use appropriate contraception during the trial
• Unstable conditions that may impair patient safety and compliance with the test
• Patients with seizure disorders requiring medication

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, Gang Nam, 676, South Korea

Location

Related Publications (1)

• (1) Bradford PT, et al. Blood 2009; 113: 5064 (2) Criscione VD, et al. Arch Dermatol 2007; 143: 854 (3) Willemze R. et al. Blood 2005; 105: 3768 (4) Li JY, et al. Cancer Manag Res 2012; 4: 75 (5) Wilcox RA. Am J Hematol 2016; 91: 152 (6) Querfeld C, et al. Blood 2014; 123: 1159 (7) Kim YH, et al. J Am Acad Dermatol 2010; 63: 975 (8) Yamamoto K, et al. J Clin Oncol 2010; 28: 1591 (9) Bose P, et al. Exp Opin Pharmacother 2014; 15: 2443 (10) Manfé V, et al. PLoS One 2013; 8: e59390 (11) Chang TP, et al. Am J Cancer Res 2013; 3: 433 (12) Chang TP, et al. J Immunol 2015; 194: 1942 (13) Ungewickell A, et al. Nat Genet 2015; 47: 1056 (14) Jagannath S, et al. Br J Haematol 2005; 129: 776 (15) Jagannath S, et al. Br J Haematol 2009; 146: 619 (16) Zinzani PL, et al. J Clin Oncol 2007; 25: 4293 (17) Kim SJ, et al. Eur J Cancer 2012; 48: 3223 (18) Moreau P, et al. Lancet Oncol 2011; 12: 431

  BACKGROUND

MeSH Terms

Interventions

Bortezomib; Dexamethasone

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Seok Jin Kim

  81, Irwon-Ro, Gangnam-Gu, Seoul, Korea 135-710

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: April 3, 2018
• Study Start: September 19, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

KR (1)