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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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

15 criteria

  • 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
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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.

What is already known about the treatment

  • Treosulfan

    An alkylating agent administered intravenously as part of high-dose chemotherapy regimens, particularly in preparation for stem cell transplantation in patients with Non-Hodgkin lymphomas. This medication works by modifying DNA structure in cancer cells, preventing them from dividing and ultimately leading to their death. It belongs to the alkylating agents class of chemotherapy drugs and is commonly used in combination with other treatments to achieve better therapeutic outcomes in advanced lymphoproliferative disorders.

  • Melphalan

    A chemotherapy medication given intravenously or orally, used in high-dose conditioning regimens before stem cell transplantation in Non-Hodgkin lymphoma patients. It functions as an alkylating agent by interfering with DNA replication in cancer cells, thereby preventing their growth and division. The drug is classified as a nitrogen mustard derivative and has been well-established in medical literature as an effective treatment option for various hematologic malignancies.

  • 90Y-Pentixather

    A radiopharmaceutical agent administered intravenously that specifically targets the CXCR4 receptor, which is commonly expressed in lymphoma cells. This therapeutic radiopharmaceutical combines a targeting molecule that binds to CXCR4 with the radioactive isotope yttrium-90, delivering targeted radiation therapy to cancer cells while minimizing exposure to healthy tissues. It represents an innovative approach in targeted molecular radiotherapy for advanced lymphoproliferative disorders.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517639-35-00Protocol codeCOLPRIT-0000-BAS-004Estimated enrolment38 patientsSponsorKlinikum der Technischen Universitaet Muenchen (TUM Klinikum)

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