Chronic lymphocytic leukaemia:

Am I eligible for the LION-1 study?

In the LION-1 study, researchers are investigating the efficacy and tolerability of a new variant of CAR-T cell therapy. Patients with chronic lymphocytic leukaemia (CLL) can also participate. However, they must meet various requirements.

When can patients with CLL participate in LION-1?

The participant must be 18 years of age or older.
The patient has no health restrictions or requires only minimal support. The study doctors use the Karnofsky Performance Status for classification.
Exception: The impairment is permanent and was present before the cancer diagnosis, for example due to a spinal cord injury.
CLL has been reliably diagnosed and is causing symptoms.
All standard therapies for CLL have been exhausted. Participants will learn which therapies this includes during the informational meeting. After the last therapy, the disease has progressed or is not responding to treatment.
The participant understands the benefits and risks of the study and consents to participate.
The patient is willing and able to attend the necessary appointments and examinations as part of the study observation.
Men must commit to either abstaining from sex or using a condom for at least one year after receiving the study drug. This also applies to men who have had a vasectomy.
Women who can become pregnant must commit to using highly effective contraception during the study period to prevent pregnancy. A pregnancy test will also be carried out as part of the preliminary examinations, which must be negative to participate in the study.
Women are not allowed to breastfeed during the study and for up to 1 year after receiving the study drug.

Which contraceptives are highly effective?

The following are considered highly effective contraceptives:

Hormone preparations containing either a combination of oestrogen and progestogen or progestogen alone, which prevent ovulation.
Intrauterine device (IUD) and hormonal IUDs.
Tubal ligation.
Vasectomy (surgical sterilisation) performed on the male partner.
Sexual abstinence.

When can patients with CLL not participate in LION-1?

If one of the above criteria does not apply.
There are indications of HIV infection.
There is an infection with syphilis or hepatitis B or C.
Exceptions are possible in certain cases and can be discussed with the study doctors.
There is an acute infection (e.g. with COVID-19) or another serious physical or mental illness.
An ultrasound examination of the heart shows that the pumping capacity of the left ventricle is too low or there are other heart problems.
The function of the liver or kidneys is too severely impaired.
There is a coagulation disorder. Exceptions are possible in certain cases and can be discussed with the study doctors.
Allogeneic stem cell therapy was performed in the 12 months prior to the collection of white blood cells (leukapheresis).
Allogeneic stem cell therapy took place more than 12 months prior to leukapheresis, and the patient has since suffered from graft-versus-host disease.
He or she has already received anti-ROR1 immunotherapy.
He or she is undergoing ongoing treatment with drugs that suppress the immune system (such as cortisone).
There is abuse of alcohol, drugs or medication.
The patient is employed by the study sponsor.
The person concerned is employed by or related to researchers involved in the study.

This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.

Back to the study description of LION-1