Lymphoma, T-Cell, CutaneousPhase 2NCT01486277
A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
A Phase 2 study testing Quisinostat, 12 mg in people with Lymphoma, T-Cell, Cutaneous, run by Janssen Research & Development, LLC at 13 sites in 6 countries.
Trial summary
The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- Quisinostat, 12 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Nov 2011to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa
- Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy)
- Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days
- Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test
- Agrees to protocol defined use of effective contraception
- Adequate laboratory function tests and bone marrow test
Who cannot join
- Prior histone-deacetylase inhibitor therapy for CTCL
- Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed)
- Major surgery or radiotherapy within 3 weeks before the start of the study medication
- Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy
- Inadequate gastrointestinal absorption status
- Use of potent inhibitors of CYP3A4/A5
- Positive human immunodeficiency virus
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
About this study
Official title: A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.
Read the detailed description
This is a single-arm (group), open-label (all people know the identity of the intervention), and multicenter study. The study consists of 3 phases including, the screening phase (within 28 days prior to the start of study medication), treatment phase (participants will receive quisinostat) and follow-up phase (30 days after the last dose of study medication until death or clinical cutoff). Clinical cut-off is defined as when the last participant will be assessed with progressive disease or died, or 6 months after the last participant enrolled, whichever occurs first. However, if any participants are still receiving study treatment at the time of clinical cut-off, these participants will enter a long-term extension phase and will continue to receive study medication until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). The long-term extension phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored in this study. Any participants responding to treatment at the end of the 2-year long-term extension phase will be able to continue to receive quisinostat as long as they are assessed by the investigator as not meeting treatment discontinuation criteria; during this time, only information related to serious adverse events will be collected.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- Quisinostat, 12 mg
- Keywords
- Lymphoma, T-Cell, Cutaneous, T-cell lymphoma, Lymphoma, Histone Deacetylase Inhibitor, JNJ-26481585
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quisinostat, 12 mgDrug
Also called JNJ 26481585
Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice).
| Study group | Role | What they receive |
|---|---|---|
| Quisinostat | Experimental | Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). Receives: Drug: Quisinostat, 12 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria
The RR is defined as the number of participants who will achieve a complete response (CR) or partial response (PR). mSWAT criteria is used to evaluate the skin tumor burden. The investigator will determine the percentage of total body surface area (TBSA) affected by patches, plaques or tumors in 12 body regions, using the participant's palm and fingers representing 1% of TBSA. CR is defined as 100% clearance of skin lesions and PR is defined as 50% to 99 % clearance of skin lesions from baseline without occurrence of a new tumor.
Measured: From screening until progressive disease or confirmed lost to follow-up or death or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Secondary outcomes (7)
Number of participants who will achieve global Response Rate (RR) based on based on consensus global response score
The RR is defined as the number of participants who will achieve a complete response (CR) or partial response (PR). Global response score provides uniformity in the assessment of response and utilizes all component of the tumor-node-metastasis-blood staging (ie, skin, nodes, viscera and blood). Complete response is defined as complete disappearance of all clinical evidence of disease (all categories have CR/ non-involved [NI]) and PR is defined as regression of measurable disease (all categories do not have a CR/NI and no category has a PD and if any other category involved at baseline, at least one has a CR or PR).
Measured: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Progression-Free Survival (PFS)
PFS is defined as the interval between the date of administration of the first dose of study medication and the date of disease progression or death from any cause, whichever occurs first.
Measured: From the date of administration of the first dose of study medication until progressive disease or death from any cause, whichever occurs first; as assessed for approximately 6 months after the enrollment of the last participant
Kaplan-Meier Estimates of 1-year overall survival (OS) rate
1-year OS rate is defined as the number of participants surviving at 1 year after the date of administration of the first dose of study medication.
Measured: From the date of administration of the first dose of study medication up to the date of progressive disease or death, whichever occurs first; as assessed up to 1 year
Duration of response (DOR) for participants achieving Complete Response (CR) or Partial Response (PR)
DOR for participants achieving a CR or PR is defined as the date from the first documentation of CR or PR until the date of first documentation of progressive disease, or death from any cause.
Measured: First documentation of CR or PR until the date of first documentation of progressive disease, or death from any cause; as assessed for approximately 6 months after the enrollment of the last participant
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening.
Measured: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Pruritus Intensity Assessment Questionnaire scale scores
Pruritus Intensity Assessment Questionnaire is an 11-point scale that requires the participant to rate the intensity of their pruritus. The scores range from '0= no pruritus; 10 = worst imaginable'. Pruritus relief will be defined as a 3 or more point decrease in participant who have a baseline pruritus score of 3 or more points or complete resolution of pruritus for 3 or more continuous weeks without an increase in the use of antipruritic medications. Higher score indicates worsening.
Measured: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Number of participants with adverse events
Measured: Up to 2 years after 6 months enrollment of the last participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486277
- Sponsor's protocol ID
- CR018640
- Other IDs
- 2011-001076-18, 26481585LYM2001
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2011
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01486277
- Acronym / sponsor ID
- CR018640
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Keywords
- Lymphoma, T-Cell, Cutaneous, T-cell lymphoma, Lymphoma, Histone Deacetylase Inhibitor, JNJ-26481585
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Dec 2011 (estimated)
- 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 purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.
Detailed description
This is a single-arm (group), open-label (all people know the identity of the intervention), and multicenter study. The study consists of 3 phases including, the screening phase (within 28 days prior to the start of study medication), treatment phase (participants will receive quisinostat) and follow-up phase (30 days after the last dose of study medication until death or clinical cutoff). Clinical cut-off is defined as when the last participant will be assessed with progressive disease or died, or 6 months after the last participant enrolled, whichever occurs first. However, if any participants are still receiving study treatment at the time of clinical cut-off, these participants will enter a long-term extension phase and will continue to receive study medication until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). The long-term extension phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored in this study. Any participants responding to treatment at the end of the 2-year long-term extension phase will be able to continue to receive quisinostat as long as they are assessed by the investigator as not meeting treatment discontinuation criteria; during this time, only information related to serious adverse events will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quisinostat | Experimental | Drug: Quisinostat, 12 mgParticipants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa
- Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy)
- Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days
- Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test
- Agrees to protocol defined use of effective contraception
Key exclusion criteria (7 listed)
- Prior histone-deacetylase inhibitor therapy for CTCL
- Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed)
- Major surgery or radiotherapy within 3 weeks before the start of the study medication
- Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy
- Inadequate gastrointestinal absorption status
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 |
|---|---|---|
| Quisinostat, 12 mgAlso: JNJ 26481585Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). | Drug | Quisinostat |
Primary outcome
Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria
Time frame: From screening until progressive disease or confirmed lost to follow-up or death or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
The RR is defined as the number of participants who will achieve a complete response (CR) or partial response (PR). mSWAT criteria is used to evaluate the skin tumor burden. The investigator will determine the percentage of total body surface area (TBSA) affected by patches, plaques or tumors in 12 body regions, using the participant's palm and fingers representing 1% of TBSA. CR is defined as 100% clearance of skin lesions and PR is defined as 50% to 99 % clearance of skin lesions from baseline without occurrence of a new tumor.
7 secondary outcomes
Number of participants who will achieve global Response Rate (RR) based on based on consensus global response score
Time frame: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Progression-Free Survival (PFS)
Time frame: From the date of administration of the first dose of study medication until progressive disease or death from any cause, whichever occurs first; as assessed for approximately 6 months after the enrollment of the last participant
Kaplan-Meier Estimates of 1-year overall survival (OS) rate
Time frame: From the date of administration of the first dose of study medication up to the date of progressive disease or death, whichever occurs first; as assessed up to 1 year
Duration of response (DOR) for participants achieving Complete Response (CR) or Partial Response (PR)
Time frame: First documentation of CR or PR until the date of first documentation of progressive disease, or death from any cause; as assessed for approximately 6 months after the enrollment of the last participant
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Pruritus Intensity Assessment Questionnaire scale scores
Time frame: From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
Number of participants with adverse events
Time frame: Up to 2 years after 6 months enrollment of the last participant
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 3 Nov 2016.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quisinostat, 12 mg in people with Lymphoma, T-Cell, Cutaneous, run by Janssen Research & Development, LLC at 13 sites in 6 countries.
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 6 inclusion and 7 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Spain, Germany, Portugal, United Kingdom and 1 more country. 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?
Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria (time frame: From screening until progressive disease or confirmed lost to follow-up or death or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2016.