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Treatment with Xeljanz in a population of patients with cutaneous T cell lymphoma
EU CTIS ID: 2022-500599-79-00
What this study is testing
Does treatment with Xeljanz decrease disease activity?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women aged 18 or older at the time of consent
- Alanine transaminase (ALT) level ≤ 2.5 times the specific institutional ULN
- Serum-creatinine ≤ 1.5 x ULN
- Negative test for tuberculosis, HIV, hepatitis B and C
- Women of childbearing potential and men must agree to use safe contraception methods during the study and minimum 4 weeks after termination of treatment
- Must be willing to participate and must be capable of giving informed consent, and the consent must be obtained prior to any study-related procedures
You likely can't join if
- Sézary syndrome (cancerous T-cells are found in the blood)
- Total cholesterol level above 6 mmol/L in blood
- Physical/laboratory/vital sign abnormalities that would, in the opinion of the investiga-tor, put the subject at undue risk or interfere with the interpretation of study results
- Active herpes simplex or herpes zoster
- Known human immunodeficiency virus, tuberculosis, hepatitis B or C
- Pregnancy or breastfeeding
See the full eligibility criteria
- Men or women aged 18 or older at the time of consent
- Alanine transaminase (ALT) level ≤ 2.5 times the specific institutional ULN
- Serum-creatinine ≤ 1.5 x ULN
- Negative test for tuberculosis, HIV, hepatitis B and C
- Women of childbearing potential and men must agree to use safe contraception methods during the study and minimum 4 weeks after termination of treatment
- Must be willing to participate and must be capable of giving informed consent, and the consent must be obtained prior to any study-related procedures
- Histologically confirmed diagnosis of Mycosis Fungoides (stage IA, IIA and IIB)
- Stable disease
- No change in medication for 2 months or 5 half-lives prior to study entry
- Must have received the yearly flu vaccine and covid-19 recommended vaccines
- Absolute neutrophil count ≥ 1 x 10^3/µL
- Platelets ≥ 100 x 10^3/µL
- Hemoglobin level ≥ 5.5 mmol/L
- Bilirubin level ≤ 1.5 times the specific institutional upper limit of normal (ULN)
- Sézary syndrome (cancerous T-cells are found in the blood)
- Total cholesterol level above 6 mmol/L in blood
- Physical/laboratory/vital sign abnormalities that would, in the opinion of the investiga-tor, put the subject at undue risk or interfere with the interpretation of study results
- Active herpes simplex or herpes zoster
- Known human immunodeficiency virus, tuberculosis, hepatitis B or C
- Pregnancy or breastfeeding
- Concomitant treatment with UVB, acitretin, interferon or bexarotene
- Psychiatric illness, disability or social situation that would compromise the safety of the subject or ability to provide consent
- Increased thromoboembolic risks (earlier thromoboembolic events)
- Ongoing infections requiring antibiotics
- Clinically significant cardiac disease (NYHA class III or IV)
- Unstable angina pectoris
- Uncontrolled hypertension (systolic blood pressure (BP) > 160 mm Hg or diastolic BP > 100 mm Hg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications
- Uncontrolled type 1 and 2 diabetes
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.