Cutaneous T-Cell LymphomaPhase 2NCT06698822
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA
A Phase 2 study testing tofacitinib 2% cream in people with Cutaneous T-Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma
- What is being tested?
- tofacitinib 2% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 19 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 screening visit. Because limited dosing and adverse event data are currently available on the use of tofacitinib in participants <18 years of age, children are excluded from this study.
- Have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy with histological findings consistent with CTCL.
- For stage IIA, only participants with a classification of N0 (no clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2) can be enrolled.
- Participants must be B0 (absence of significant blood involvement: .5% of peripheral blood lymphocytes of <250/mcL are atypical.
- Have at least 2 distinct lesions that have either failed or recurred despite treatment with 1 previous standard therapy.
- ECOG performance status ≤ 2 (Karnofsky .60%)
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- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of tofacitinib on the developing human fetus are unknown. Available data with tofacitinib in its oral formulation in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months)
- History of hysterectomy or bilateral salpingo-oophorectomy
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
- History of bilateral tubal ligation or another surgical sterilization procedure
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of tofacitinib administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tofacitinib
- Skin infection and/or skin ulceration at screening and baseline visit
- Any subject with a diagnosis of active malignancy or a cancer requiring treatment of expected to require treatment during the course of the trial (not including basal cell carcinoma, squamous cell carcinoma of the skin, malignant melanoma in situ, or cervical carcinoma in situ)
- Any uncontrolled or serious underlying disease or medical or surgical condition that may interfere with interpretation of the trial results and/or place the subject at significant risk according to investigator discretion including but not limited to severe cardiac, psychiatric, hematologic, and thyroid conditions
- History of Stage IIB or greater CTCL, or stage IIA CTCL with history of stage N2 (Dutch Grade 2 or NCI LN3 or greater), or with >5% circulating Sezary cells
- History of aggressive CD8+ CTCL disease
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- Having received one of the following treatments within the specified timeframes (calculated from baseline visit):
- In the past 12 weeks: Total Skin Electron Beam Therapy (TSEBT)
- In the past 8 weeks: topical imiquimod
- In the past 4 weeks: topical corticosteroids, topical chemotherapy, topical retinoids, local radiation therapy, UVB therapy, PUVA, photopheresis, systemic retinoids, systemic corticosteroids, interferon inducers, systemic chemotherapeutic agents
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia
- Participants who are receiving any other investigational agents
- Participants with uncontrolled intercurrent illness
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Participants with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because the effects of tofacitinib on the developing human fetus are unknown. As there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with tofacitinib, breastfeeding should be discontinued if the mother is treated with tofacitinib. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Juila Dai, MD, 713-515-7961, jdai6@mdanderson.org
Julia Dai, MD
About this study
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.
Read the detailed description
Primary Objectives
- To assess the safety of tofacitinib 2% cream in the treatment of early stage CTCL (stage IA, IB, or IIA)
- To assess the overall response rate (ORR) of target lesions at Week 12 based upon Modified Composite Assessment of Index Lesion Severity (mCAILS)
Secondary Objectives
- To assess the overall response rate (ORR) of target lesions at Week 12 based upon mSWAT composite score
- To assess response by mCAILS at weeks 20, 28, 36, 44, and 52 for participants that choose to extend treatment
- To assess the time to overall response by mCAILS score
- To assess the duration of overall response by mCAILS score
- To assess pruritus using the visual analog scale at baseline, 4 weeks, 8 weeks, and 12 weeks
- To assess health-related quality of life using the Skindex-29 instrument at baseline, 4 weeks, 8 weeks, and 12 weeks To characterize the JAK/STAT biomarker profile of tumors and characterize the mutational landscape in tumors before and after therapy
- Conditions
- Cutaneous T-Cell Lymphoma
- Being tested
- tofacitinib 2% cream
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tofacitinib 2% creamDrug
Given topical
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib 2% | Experimental | Participants will apply a thin layer of tofacitinib 2% cream 2 times a day on up to 5 treatment-eligible skin lesions. Receives: Drug: tofacitinib 2% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AE's)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start10 Mar 2025
- Primary completion19 Jun 2027 (estimated)
- Study completion19 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Dai, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698822
- Sponsor's protocol ID
- 2023-0747
- Other IDs
- NCI-2024-09674
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA
- ClinicalTrials.gov ID
- NCT06698822
- Acronym / sponsor ID
- 2023-0747
- Conditions
- Cutaneous T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.
Detailed description
Primary Objectives
- To assess the safety of tofacitinib 2% cream in the treatment of early stage CTCL (stage IA, IB, or IIA)
- To assess the overall response rate (ORR) of target lesions at Week 12 based upon Modified Composite Assessment of Index Lesion Severity (mCAILS)
Secondary Objectives
- To assess the overall response rate (ORR) of target lesions at Week 12 based upon mSWAT composite score
- To assess response by mCAILS at weeks 20, 28, 36, 44, and 52 for participants that choose to extend treatment
- To assess the time to overall response by mCAILS score
- To assess the duration of overall response by mCAILS score
- To assess pruritus using the visual analog scale at baseline, 4 weeks, 8 weeks, and 12 weeks
- To assess health-related quality of life using the Skindex-29 instrument at baseline, 4 weeks, 8 weeks, and 12 weeks To characterize the JAK/STAT biomarker profile of tumors and characterize the mutational landscape in tumors before and after therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib 2% | Experimental | Drug: tofacitinib 2% creamParticipants will apply a thin layer of tofacitinib 2% cream 2 times a day on up to 5 treatment-eligible skin lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years at screening visit. Because limited dosing and adverse event data are currently available on the use of tofacitinib in participants <18 years of age, children are excluded from this study.
Key exclusion criteria (16 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tofacitinib
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 |
|---|---|---|
| tofacitinib 2% creamGiven topical | Drug | Tofacitinib 2% |
Primary outcome
Safety and adverse events (AE's)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Julia Dai, MD principal investigator
M.D. Anderson Cancer Center
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 tofacitinib 2% cream in people with Cutaneous T-Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 15 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Dai, MD (713-515-7961, jdai6@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AE's) (time frame: Through study completion; an average of 1 year). 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 13 Jul 2026.