Study on the Safety and Effectiveness of [90Y]Y-PentixaTher in Patients with Recurrent or Resistant CNS Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called central nervous system (CNS) lymphoma, which can be either primary or secondary and is known to be recurrent or resistant to treatment. The study is testing a new treatment called [90Y]Y-PentixaTher, which is a solution for injection. This treatment involves a special type of therapy known as endoradiotherapy, which uses a radioactive substance to target and treat cancer cells. The main goal of the study is to evaluate the safety and how well patients can tolerate different doses of this treatment.

Participants in the study will receive a single dose of [90Y]Y-PentixaTher. Before receiving this treatment, patients will undergo a scan using another substance called [68Ga]Ga-PentixaFor to confirm the presence of a specific marker, known as CXCR4, on their cancer cells. This marker helps identify patients who might benefit from the treatment. The study will monitor how the treatment spreads in the body and its effects on the cancer, as well as any side effects or changes in health indicators like blood tests and vital signs.

In addition to the main treatment, some patients may receive a solution called LysaKare, which contains L-lysine hydrochloride and L-arginine hydrochloride. This solution is given through an infusion and is used to help protect the kidneys during the treatment. The study aims to find the best dose of [90Y]Y-PentixaTher for future research and to gather information on how effective it is in treating CNS lymphoma. The trial is expected to continue until November 2025.

1 Initial assessment and preparation

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A [68Ga]Ga-PentixaFor PET scan is performed to confirm the presence of CXCR4 on tumor lesions. This scan must be done within two months prior to enrollment or during the screening phase.

2 Baseline measurements

Baseline measurements are taken, including vital signs, laboratory tests (hematology, biochemistry, urinalysis), and a 12-lead ECG.

These measurements help establish a reference point for monitoring changes during the trial.

3 Administration of LysaKare

The patient receives LysaKare 25 g/25 g solution for infusion to protect the kidneys during the treatment. This is administered as a solution for infusion.

4 Treatment with [90Y]Y-PentixaTher

The patient receives a single dose of [90Y]Y-PentixaTher as a solution for infusion. This treatment is designed to target and treat the lymphoma.

The dose is determined based on the study’s dose escalation protocol to assess safety and tolerability.

5 Monitoring and follow-up

After treatment, the patient is monitored for any side effects or adverse events. This includes regular checks of vital signs, laboratory tests, and physical examinations.

Follow-up assessments are conducted at one month, three months, and twelve months to evaluate the treatment’s efficacy and any long-term effects.

Who Can Join the Study?

The patient or their legal guardian must sign a consent form before any study activities begin.
If the patient is a male with a partner who can become pregnant, they must agree to use effective birth control during the study and for six months after treatment.
The patient must have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
The patient must have a confirmed presence of CXCR4 on their tumor, shown by a special scan called a PET scan within two months before joining the study.
Blood test results must meet specific criteria:
- Absolute neutrophil count: More than 1.0 x 10⁹ per liter
- Hemoglobin: At least 8 grams per deciliter
- Platelets: At least 75 x 10⁹ per liter
- Liver enzymes (ALT, AST, ALP): No more than 3 times the normal limit
- Serum creatinine: No more than 2 times the normal limit and a GFR of at least 50 mL/min
- Bilirubin: No more than 3 times the normal limit
The patient must be over 18 years old.
The patient must weigh 180 kg or less.
The patient must have at least one measurable lymphoma in the central nervous system (CNS), either in the brain or in the protective layers around the brain.
The patient must have a confirmed diagnosis of relapsed or refractory primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). This means the lymphoma has returned or did not respond to initial treatment.
The patient must have stored stem cells with at least 2 x 10⁶ CD34+ cells per kg of body weight. These are special cells that can help in recovery after treatment.
If the patient is a sexually active female who can become pregnant, she must agree to use effective birth control during the study and for six months after the last dose.
If the patient is a female who cannot become pregnant, she must have a documented history of procedures like tubal ligation or hysterectomy, or be post-menopausal.

Who Cannot Join the Study?

Patients who do not have central nervous system (CNS) lymphoma. This is a type of cancer that affects the brain or spinal cord.
Patients whose CNS lymphoma is not recurrent or refractory. Recurrent means the cancer has come back after treatment, and refractory means it does not respond to treatment.
Patients who do not have CXCR4-positive CNS lymphoma. CXCR4 is a specific protein found on the surface of some cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of a vulnerable population.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Ufgzjmnvrgqgjsitfgmpv Elexk Avb	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	23.10.2023

Trial locations

Investigated drugs:

[90Y]Y-PentixaTher is a type of endoradiotherapy used in this clinical trial. It is designed to treat patients with primary or isolated secondary central nervous system lymphoma that is recurrent or does not respond to other treatments. This therapy works by targeting a specific receptor, known as C-X-C chemokine receptor 4 (CXCR4), which is present on the cancer cells. The goal of the trial is to find out how safe and tolerable this treatment is and to determine the best dose for future studies.

Investigated diseases:

Neoplasm malignant

Central Nervous System Lymphoma – This is a type of cancer that occurs in the lymphatic tissue of the brain or spinal cord. It can be classified as primary, originating in the central nervous system, or secondary, spreading from other parts of the body. The disease is characterized by the uncontrolled growth of lymphocytes, a type of white blood cell, within the central nervous system. Symptoms may include headaches, seizures, and changes in personality or behavior, depending on the tumor’s location. As the disease progresses, it can lead to neurological deficits and cognitive impairments. The condition is considered rare and can be challenging to manage due to its location within the central nervous system.

Trial ID:

2024-512097-98-00

Protocol code:

PTT101

NCT ID:

NCT06132737

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of [90Y]Y-PentixaTher in Patients with Recurrent or Resistant CNS Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?