LYMPHIR (denileukin diftitox-cxdl) Injection 300 mcg

Observational Study of Patients
with Cutaneous T-cell Lymphoma (CTCL)
treated with LYMPHIR™


This is an observational research study for people with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who are planning to begin treatment with LYMPHIR.

An observational research study means participants will continue to receive care as decided by their healthcare providers. Participation in this study will not change participants’ treatment or medical care in any way.

About the LYMPHIR study

This study is evaluating side effects in people living with cutaneous T-cell lymphoma (CTCL) who are receiving treatment with LYMPHIR™. LYMPHIR is a treatment option for patients whose disease has returned (relapsed) or has not responded to prior therapies (refractory). If you choose to join the study, your regular medical care will not change. You will continue to receive LYMPHIR as prescribed by your doctor, and you will not receive any extra treatments or medical tests just for being in the study.

The study team will collect information from your routine medical care and may ask you to complete questionnaires about how you are feeling and how treatment affects your daily life.

Information collected during the study may include:

  • At enrollment: Information about your CTCL diagnosis, medical history, age, current health status, laboratory test results, height, weight, and medications.
  • During follow-up visits: Updates on your treatment, medications, side effects, test results, weight, and how your cancer is responding to treatment.
  • Patient questionnaires: At scheduled time points, you will be asked to complete brief surveys about your symptoms, daily activities, overall health, and quality of life.
  • Optional tokenization: If you choose to participate, a unique code that does not contain any personal identifying information will be assigned to you. This code may be used to link data from your electronic medical records during the study.

You will be followed for up to 24 months after your first LYMPHIR infusion. This longer follow-up period will help researchers better understand the long-term safety of LYMPHIR and how patients respond to treatment over time.


Why Participate?

CTCL is a rare form of cancer that primarily affects the skin, including sensitive areas such as the skin around the eyes. Because this area is delicate and closely connected to the eyes, the disease can sometimes lead to ocular complications. There is a risk of visual complications with LYMPHIR. These complications may affect eye function and, in some cases, result in vision impairment which may be only temporary.

This study is designed to help doctors better understand why CTCL treatment with LYMPHIR may be causing certain side effects and how long those side effects may last. It looks at how LYMPHIR is used in everyday care, how patients do overtime, and how doctors may improve CTCL treatment with LYMPHIR in the future.

The results may also help healthcare providers better recognize and manage possible eye-related side effects.

Your participation in the study is strictly voluntary. You may withdraw from the study at any time.

Who Can Participate?

You may be able to join if you:

  • Have been diagnosed with CTCL
  • Have been prescribed LYMPHIR by your doctor, but you have not started treatment yet
  • Have had an eye exam in the last 3 months, or are willing to have one before your first LYMPHIR treatment
  • Are able to read and provide informed electronic consent (eConsent)

More Information for Patients

Patient Information Brochure
Download

Patient Information Brochure

and
Patient Study Guide
Download

Patient Study Guide

How to Enroll

Interested in joining the LYMPHIR study? Share your contact information, and a study team member will follow up.

Provide Your Contact Information

For Healthcare Providers:
To refer an eligible patient who is interested in participating in the LYMPHIR study, please contact the study team:

To speak to a study team representative, contact the
LYMPHIR study toll-free at:

Phone number

Call 833-610-4660

Hours of operation

Hours of Operation:
Monday – Friday, 8am – 8pm ET