A Study of PTX-100 for Patients with Cutaneous T-Cell Lymphoma That Has Returned or Did Not Respond to Previous Treatment

Treatment phase with PTX-100

During this phase, you will receive PTX-100, which is a medication given through an intravenous infusion. This means the medication will be delivered directly into your vein through a drip.

The medication is provided as a solution for infusion, which is a liquid form prepared specifically for administration through your vein.

The treatment will be administered according to a schedule determined by the study protocol. The exact dosage, frequency, and duration will be determined based on the study design.

Regular monitoring and assessments

Throughout the study, your condition will be monitored regularly to evaluate how the treatment is working and to check for any side effects.

Your skin lesions will be assessed using a measurement tool called mSWAT, which helps track changes in your skin condition.

Blood samples will be taken to check for atypical or malignant lymphocytes, which are abnormal white blood cells that may be present in your blood.

If applicable, any disease outside the skin will be measured using specific imaging criteria.

Your vital signs, including blood pressure, heart rate, and temperature, will be checked regularly.

Blood tests will be performed to monitor your bone marrow function, including counts of different blood cells such as neutrophils (a type of white blood cell), platelets (cells that help blood clot), and hemoglobin (the protein in red blood cells that carries oxygen).

Your liver function will be monitored by measuring levels of bilirubin (a substance produced when red blood cells break down), alanine aminotransferase, and aspartate aminotransferase (enzymes that indicate liver health).

Your kidney function will be assessed by measuring creatinine levels and calculating creatinine clearance, which shows how well your kidneys are filtering waste from your blood.

Your blood clotting function will be checked by measuring INR (International Normalized Ratio) and activated partial thromboplastin time, which are tests that show how quickly your blood clots.

An electrocardiogram (a test that records the electrical activity of your heart) will be performed to monitor your heart function.

Your ECOG performance status will be assessed, which is a scale from 0 to 5 that measures how the disease affects your daily living abilities.

Safety monitoring

Any adverse events, which are unwanted or harmful reactions that may occur during treatment, will be recorded and assessed for their severity and nature.

Changes in your laboratory test results, vital signs, heart function, and performance status will be compared to your baseline measurements taken before treatment started.

Pharmacokinetic assessments

Pharmacokinetic assessments will be conducted, which means blood samples will be taken to measure how the medication moves through your body over time.

These measurements will include how much medication is in your blood at its highest point, how long it takes to reach that point, the lowest level between doses, and how long the medication stays in your body before being eliminated.

Response evaluation

Your response to treatment will be evaluated to determine if the disease is getting better, staying the same, or getting worse.

The study will track several outcomes, including the overall response rate, how long any response lasts, how long it takes for a response to occur, whether you achieve a complete response (meaning no signs of disease), and how long you survive without the disease getting worse.

The time until you might need another treatment will also be recorded.

Follow-up period

After completing the treatment phase, you will enter a follow-up period where your health status and disease progression will continue to be monitored.

This follow-up will help assess long-term outcomes such as overall survival and progression-free survival, which measures how long you live without the disease getting worse.