Cutaneous T-Cell Lymphoma/Mycosis FungoidesPhase 1NCT04702503
Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL)
A Phase 1 study testing WP1220 in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Moleculin Biotech, Inc. at 1 site in Poland.
Trial summary
Single center, pilot study to evaluate the safety and efficacy topical administration of WP1220 in subjects with Stage I, II or III Mycosis Fungoides (CTCL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- What is being tested?
- WP1220
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePoland
- Study dates
- 8 Mar 2019to 15 Nov 2020
- Phase
- Phase 1
- 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
- Age ≥ 18 years at the time of signing informed consent.
- Clinical diagnosis of MF.
- Stage IA, IB, IIA, IIB, or II MF: T1-T4 with measurable lesions
- Previously treatment with at least one standard therapy used to treat Stage IA, IB, IIA, IIB, or III MF.
- Measurable skin disease must have at least 2 eligible baseline index lesions with maximum total area ≤ 40 cm2. Eligible lesions must be below the head (face and scalp are excluded) and must not involve the genitalia or anus.
- ECOG performance status of 0-2
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- Subject must read and sign informed consent form and be willing to comply with the instructions, restrictions, nature and procedures of the study.
- Willing to avoid tanning devices or exposure of the treated skin to the sun.
- Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
- Willing to use topical steroid on a maximum of 25% of BSA occupied by MF on areas not involved in the clinical trial.
- Must have recovered from the effects of surgery requiring general anesthesia and intubation for a minimum of 3 months, and from minor surgery requiring only local anesthetic for a minimum of 2 weeks.
- Concomitant disease must be stable and subjects must be on the same dose and schedule of any medications for at least 1 month before screening.
- Subjects of both genders who are of childbearing potential including perimenopausal women who are fewer than 2 years from their last menses, must use one of the following effective means of contraceptionL
- Birth control pills in conjunction with spermicide gel
- Surgical sterilization
- Intra uterine device
- Condom and spermicide gel together
- Sexual abstinence during study period
- The requirements above do not apply to:
- Postmenopausal women with spontaneous amenorrhea for at least 2 years, or
- Subjects with bilateral oophoerctomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- Subjects with total hysterectomy and an absence of bleeding for at least 3 months
Who cannot join
- MF with no prior therapy.
- Subjects with a diagnosis of stage IV MF at Screening or subsequently observed at Baseline.
- Subjects with unusual phenotypes, e.g. lymphomatoid papulosis MF-like type.
- Subjects who require immediate treatment for progressive MF.
- Subjects treated with at least one of the following methods within 8 weeks prior to
- Baseline:
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- Total body electron beam radiation
- Investigational drugs or treatments
- Subjects treated with at least one of the following methods within 4 weeks prior to
- Baseline:
- Local radiation therapy
- UVB therapy
- PUVA
- Topical chemotherapy
- Topical corticosteroids or retinoids
- Systemic chemotherapeutic agents (excluding low doses of MTX max. 25 mg/wk)
- Index lesion treatment with at least one of the following methods within 2 weeks prior to Baseline:
- Any surgical procedures other than biopsies related to CTCL diagnosis or follow- up
- Any topical treatment other than bland moisturizers (creams, lotions, emollients, etc)
- Skin infections on screening or baseline involving index lesions planned to be treated in the clinical trial.
- The presence of any clinically significant laboratory abnormalities at screening including, but not limited to abnormalities of the white blood count, hemoglobin, platelets, serum chemistry (glucose, uric acid, calcium, phosphorus, sodium, potassium, chloride, alkaline phosphatase, albumin and total bilirubin), thyroid stimulating hormone, fT3 and fT4 as determined by the Investigator in conjunction with the Medical Monitor.
- Any significant uncontrolled medical disease as evaluated by the Investigator and/or Medical Monitor, chronic or active within the past 6 months, including but not limited to, cardiac disease, seizure disorder, liver disease, renal disease, chronic infection, uncontrolled diabetes, lung disease.
- Any prior history or active malignancy other than MF.
- Subjects in deep depression.
- Subjects who are not mentally capable of understanding the protocol and all procedures.
- Subjects who do not agree to have the necessary blood draws and procedures for laboratory tests and evaluations according to protocol.
- Known allergy to any active or inactive ointment ingredient.
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Study Evaluating the Safety and Efficacy of Topical Administration of WP1220, an Inhibitor of STAT3 Activation, in Adults With Stage I, II, or III Mycosis Fungoides (Cutaneous T-Cell Lymphoma, CTCL)
Single center, pilot study to evaluate the safety and efficacy topical administration of WP1220 in subjects with Stage I, II or III Mycosis Fungoides (CTCL)
- Being tested
- WP1220
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WP1220Drug
Topical administration 2x daily for 84 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 10% WP1220 ointment | Experimental | 10% WP1220 ointment topically applied 2x day for 84 days Receives: Drug: WP1220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety profile of WP1220 applied topically (adverse events)
Safety will be evaluated by reported adverse events
Measured: 12 weeks (3 28-day cycles)
Secondary outcomes (1)
Evaluation of WP1220 applied topically to index lesions via standard measurement scale
Efficacy to be demonstrated through ≥50% improvement in standard assessments of lesions in comparison to baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start8 Mar 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell Lymphoma/Mycosis FungoidesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleculin Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Silberman, MD, PhD, Study director, Moleculin Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702503
- Sponsor's protocol ID
- MB-201
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2019
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety and Efficacy of Topical Administration of WP1220, an Inhibitor of STAT3 Activation, in Adults With Stage I, II, or III Mycosis Fungoides (Cutaneous T-Cell Lymphoma, CTCL)
- ClinicalTrials.gov ID
- NCT04702503
- Acronym / sponsor ID
- MB-201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Moleculin Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 11 Jan 2021 (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.
Single center, pilot study to evaluate the safety and efficacy topical administration of WP1220 in subjects with Stage I, II or III Mycosis Fungoides (CTCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10% WP1220 ointment | Experimental | Drug: WP122010% WP1220 ointment topically applied 2x day for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Clinical diagnosis of MF.
- Stage IA, IB, IIA, IIB, or II MF: T1-T4 with measurable lesions
- Previously treatment with at least one standard therapy used to treat Stage IA, IB, IIA, IIB, or III MF.
- Measurable skin disease must have at least 2 eligible baseline index lesions with maximum total area ≤ 40 cm2. Eligible lesions must be below the head (face and scalp are excluded) and must not involve the genitalia or anus.
Key exclusion criteria (28 listed)
- MF with no prior therapy.
- Subjects with a diagnosis of stage IV MF at Screening or subsequently observed at Baseline.
- Subjects with unusual phenotypes, e.g. lymphomatoid papulosis MF-like type.
- Subjects who require immediate treatment for progressive MF.
- Subjects treated with at least one of the following methods within 8 weeks prior to
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 |
|---|---|---|
| WP1220Topical administration 2x daily for 84 consecutive days | Drug | 10% WP1220 ointment |
Primary outcome
Evaluation of the safety profile of WP1220 applied topically (adverse events)
Time frame: 12 weeks (3 28-day cycles)
Safety will be evaluated by reported adverse events
1 secondary outcome
Evaluation of WP1220 applied topically to index lesions via standard measurement scale
Time frame: 12 weeks
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 11 Jan 2021.
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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.
Sandra Silberman, MD, PhD study director
Moleculin Biotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WP1220 in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Moleculin Biotech, Inc. at 1 site in Poland.
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 22 inclusion and 28 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 11 Jan 2021. 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 Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluation of the safety profile of WP1220 applied topically (adverse events) (time frame: 12 weeks (3 28-day cycles)). 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 11 Jan 2021.