Study of [90Y]Y-PentixaTher and [68Ga]Ga-PentixaFor in patients with advanced Non-Hodgkin lymphomas: Evaluating radiopeptide-based imaging and therapy

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What is this study about?

This clinical trial focuses on treating patients with Non-Hodgkin lymphomas, an advanced type of blood cancer that affects the lymphatic system. The study uses two medications: [68Ga]Ga-PentixaFor, which helps create detailed images of cancer cells, and [90Y]Y-PentixaTher, which is used for treatment. Both medications are given as solutions that are injected into a vein.

The study aims to determine the most effective and safe dose of [90Y]Y-PentixaTher when used together with high-dose chemotherapy, followed by stem cell transplantation. The treatment approach targets a specific protein called CXCR4 that is found on cancer cells. Before receiving treatment, patients undergo special imaging tests to confirm whether their cancer cells have this protein.

The trial is conducted in two phases. In the first phase, different doses of the treatment will be tested to find the safest amount that can be given to patients. In the second phase, researchers will study how well the treatment works at the chosen dose. Throughout the study, patients will receive regular medical check-ups to monitor their response to treatment and any side effects that may occur.

1 Initial imaging examination

You will undergo a PET/CT scan using a substance called [68Ga]Ga-PentixaFor, which is given through an intravenous injection

For patients with multiple myeloma, a PET/MR scan may be used instead

2 Bone marrow examination

A bone marrow sample will be taken to assess the presence of specific markers

This examination helps determine if your condition is suitable for the treatment

3 Stem cell verification

Your previously stored stem cells will be checked to ensure there are enough cells available (more than 2 million cells per kilogram of body weight)

These cells are necessary for the transplant phase of the treatment

4 Treatment administration

You will receive an intravenous injection of [90Y]Y-PentixaTher

This will be combined with high-dose chemotherapy

The chemotherapy may include medications such as Melphalan or Treosulfan

5 Stem cell transplantation

After the treatment, you will receive your own stem cells back through an autologous stem cell transplantation

This procedure helps your body recover from the high-dose treatment

6 Follow-up monitoring

Your blood counts will be regularly monitored to track recovery

The medical team will assess your response to the treatment

You will be monitored for any side effects or adverse reactions

Who Can Join the Study?

Must be at least 18 years old
Must have a confirmed diagnosis of either:
- Multiple myeloma that has progressed after standard treatments, or
- Aggressive B- and T-cell lymphomas that have returned or not responded to at least 2 previous treatments
Must have a positive result on a special imaging test called 68Ga-Pentixafor PET/CT or PET/MR for multiple myeloma patients
Must have stored stem cells available (more than 2 million cells per kilogram of body weight)
Must have good enough physical condition to perform daily activities (ECOG score 0-1) and life expectancy of more than 3 months
Must have adequate organ function, including:
- Liver function tests within acceptable limits
- Kidney function (creatinine clearance above 40ml/min)
- Good heart and lung function
Must provide written informed consent
For women who can become pregnant:
- Must not be breastfeeding
- Must use effective birth control
- Must have a negative pregnancy test
For men who can father children:
- Must use effective birth control methods
- Must continue contraception for 90 days after treatment

Who Cannot Join the Study?

Age below 18 years or above 75 years
Pregnant or breastfeeding women
Known allergy or hypersensitivity to study medications
Active, uncontrolled infections
Severe kidney dysfunction (as this may affect medication processing)
Severe liver dysfunction (as this may affect medication processing)
Participation in another clinical trial within the last 30 days
Inability to provide informed consent
Previous stem cell transplantation (a procedure where healthy blood-forming cells replace damaged ones)
Uncontrolled heart conditions
Active secondary cancer (cancer that has spread from another part of the body)
Mental conditions that could interfere with study compliance
Bone marrow involvement exceeding 25% (bone marrow is the soft tissue inside bones where blood cells are made)
Low blood cell counts (neutrophils below 1,000/µL or platelets below 50,000/µL)
Life expectancy less than 3 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Uwkxrsmrgxzpsnrhmvies Amazlxjz	Augsburg	Germany
Koevienn dmh Uxokytrouvbq Mdggrrpm Aip	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	02.09.2024

Trial locations

Investigated drugs:

Pentixather (labeled with Yttrium-90) is a radioactive drug that targets specific proteins (CXCR4 receptors) found on cancer cells. It is used for both imaging and treatment of advanced blood cancers. The medication delivers radiation directly to cancer cells, helping to destroy them while minimizing damage to healthy tissue.

Melphalan is a chemotherapy medication used to treat various types of blood cancers. It works by interfering with cancer cell DNA, preventing these cells from growing and multiplying.

Treosulfan is a chemotherapy drug used in high-dose treatments, particularly before stem cell transplantation. It helps eliminate cancer cells and prepares the body for the transplant procedure.

These medications are used in combination with autologous stem cell transplantation (autoSCT), a procedure where a patient’s own healthy blood-forming cells are collected and later returned to help restore the body’s ability to produce healthy blood cells after high-dose chemotherapy.

Investigated diseases:

Non-Hodgkin's lymphoma

Non-Hodgkin Lymphoma – A group of blood cancers that develop from lymphocytes, a type of white blood cell found in the lymphatic system. The disease can start in various parts of the body, including lymph nodes, spleen, bone marrow, or other organs. It typically begins when healthy lymphocytes change and grow uncontrollably, forming tumors. The condition can progress at different rates, with some forms developing slowly while others grow more rapidly. The lymphatic system becomes increasingly affected as abnormal lymphocytes accumulate and form masses in various locations throughout the body.

Trial ID:

2024-517639-35-00

Protocol code:

COLPRIT-0000-BAS-004

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of [90Y]Y-PentixaTher and [68Ga]Ga-PentixaFor in patients with advanced Non-Hodgkin lymphomas: Evaluating radiopeptide-based imaging and therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?