Cutaneous T-Cell Lymphoma (CTCL)Phase 2NCT02213861
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
A Phase 2 study testing SHAPE in people with Cutaneous T-Cell Lymphoma (CTCL), run by TetraLogic Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma (CTCL)
- What is being tested?
- SHAPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2014to Oct 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
- Histological confirmation of CTCL; a documented verifiable biopsy report is required
- Documented clinical stage IA, IB or IIA CTCL
- Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
- ECOG performance status of 0-2
Who cannot join
- CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
- Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
- Any prior history of hematologic malignancy (other than CTCL) within past 5 years
- CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
- Prior or concurrent central nervous system (CNS) metastases
Show all 9Show fewer
- History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
- Evidence of active Hepatitis B or C or HIV
- Circulating atypical cells of clinical significance
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern Medical Group
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Stanford Cancer Center
Stanford, California, 94305
About this study
Official title: A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).
Read the detailed description
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
- Conditions
- Cutaneous T-Cell Lymphoma (CTCL)
- Being tested
- SHAPE
- Keywords
- CTCL, Cutaneous T-Cell Lymphoma, Early-stage, SHAPE, SHP-141, topical, Histone deacetylase inhibitor, CAILS, mSWAT, mycosis fungoides
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPEDrug
Also called SHP-141
topical gel
| Study group | Role | What they receive |
|---|---|---|
| 1.0% SHAPE Gelled Solution once daily | Experimental | Not described Receives: Drug: SHAPE |
| 0.5% SHAPE Gelled Solution twice daily | Experimental | Not described Receives: Drug: SHAPE |
| 1.0% SHAPE Gelled Solution twice daily | Experimental | Not described Receives: Drug: SHAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
Measured: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Secondary outcomes (4)
modified Severity Weighted Assessment Tool (mSWAT)
Measured: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Patient assessment of pruritis using a Visual Analog Scale (VAS)
Measured: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Skindex-29 Quality of Life Tool
Measured: Every 4 weeks for 26 weeks
modified Composite Assessment of Index Lesion Severity (CAILS)
Measured: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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 Cutaneous T-Cell Lymphoma (CTCL)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TetraLogic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213861
- Sponsor's protocol ID
- SHP-141-003
- Status last verified
- Oct 2016
- First submitted
- 6 Aug 2014
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02213861
- Acronym / sponsor ID
- SHP-141-003
- Conditions
- Cutaneous T-Cell Lymphoma (CTCL)
- Keywords
- CTCL, Cutaneous T-Cell Lymphoma, Early-stage, SHAPE, SHP-141, topical, Histone deacetylase inhibitor, CAILS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TetraLogic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 12 Aug 2014 (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 evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).
Detailed description
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.0% SHAPE Gelled Solution once daily | Experimental | Drug: SHAPE |
| 0.5% SHAPE Gelled Solution twice daily | Experimental | Drug: SHAPE |
| 1.0% SHAPE Gelled Solution twice daily | Experimental | Drug: SHAPE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological confirmation of CTCL; a documented verifiable biopsy report is required
- Documented clinical stage IA, IB or IIA CTCL
- Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
- ECOG performance status of 0-2
Key exclusion criteria (9 listed)
- CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
- Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
- Any prior history of hematologic malignancy (other than CTCL) within past 5 years
- CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
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 |
|---|---|---|
| SHAPEAlso: SHP-141topical gel | Drug | 0.5% SHAPE Gelled Solution twice daily, 1.0% SHAPE Gelled Solution once daily, 1.0% SHAPE Gelled Solution twice daily |
Primary outcome
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
4 secondary outcomes
modified Severity Weighted Assessment Tool (mSWAT)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Patient assessment of pruritis using a Visual Analog Scale (VAS)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Skindex-29 Quality of Life Tool
Time frame: Every 4 weeks for 26 weeks
modified Composite Assessment of Index Lesion Severity (CAILS)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Derived from this study: PubMed 32632956Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHAPE in people with Cutaneous T-Cell Lymphoma (CTCL), run by TetraLogic Pharmaceuticals at 5 sites in United States.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Results are not available in the source record.
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?
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity) (time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).). 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 NCT02213861, 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 20 Oct 2016.