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

October 23, 2020 updated by: Kim, Seok Jin, Samsung Medical Center

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gang Nam
      • Seoul, Gang Nam, Korea, Republic of, 676
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • If you have substance abuse, medical, mental or social illnesses that may interfere with the patient's participation in the clinical trial or the evaluation of clinical trial results
  • Patients with a history of hypersensitivity to Drug or Drug component (bortezomib, boron, mannitol, dexamethasone)
  • Patients with Acute Diffuse Invasive Pulmonary Disease and Cardiovascular Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: bortezomib/dexamethasone
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate of tumor
Time Frame: Through study completion, an average of 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
progressive-free survival
Time Frame: 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
the time interval between the first clinical trial dosing date and the first occurring date of tumor progression or death (due to all causes) Duration of response: The time from the first documentation of the objective tumor response to the time of disease progression or death (due to all causes)
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
Time Frame: An average of 6 years
Percentage of subjects who achieved complete remission, partial remission, or stable lesions as a result of tumor response
An average of 6 years
Duration of response
Time Frame: 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
The time from the first documentation of the objective tumor response to the time of disease progression or death (due to all causes)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Seok Jin Kim, 81, Irwon-Ro, Gangnam-Gu, Seoul, Korea 135-710

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • (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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-02-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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