Relapsed and/or Refractory Cutaneous T-cell LymphomaPhase 2NCT03487133
Bortezomib/Dexamethasone Therapy in Patients With Relapsed and/or Refractory Cutaneous T-cell Lymphoma
A Phase 2 study testing bortezomib/dexamethasone in people with Relapsed and/or Refractory Cutaneous T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Relapsed and/or Refractory Cutaneous T-cell Lymphoma
- What is being tested?
- bortezomib/dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2017to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- 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
Read the 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.
- Being tested
- bortezomib/dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib/dexamethasoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: bortezomib/dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate of tumor
Overall response rate (complete remission, partial remission) according to the ISCL-USCLC-EORTC recommendation evaluated by institutional investigators
Measured: Through study completion, an average of 3 years
Secondary outcomes (3)
progressive-free survival
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)
Measured: 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
Percentage of subjects who achieved complete remission, partial remission, or stable lesions as a result of tumor response
Measured: An average of 6 years
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start19 Sep 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed and/or Refractory Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim, Seok Jin, Samsung Medical Center
- Investigators
- Seok Jin Kim, Study chair, 81, Irwon-Ro, Gangnam-Gu, Seoul, Korea 135-710
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487133
- Sponsor's protocol ID
- 2017-02-104
- Status last verified
- Oct 2020
- First submitted
- 18 Jan 2018
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03487133
- Acronym / sponsor ID
- 2017-02-104
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bortezomib/dexamethasone | Experimental | Drug: bortezomib/dexamethasoneSubjects 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib/dexamethasoneInduction 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 | Drug | bortezomib/dexamethasone |
Primary outcome
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
3 secondary outcomes
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
Disease stabilization rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background(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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Jin Kim study chair
81, Irwon-Ro, Gangnam-Gu, Seoul, Korea 135-710
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib/dexamethasone in people with Relapsed and/or Refractory Cutaneous T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate of tumor (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.