Lymphoma – Trials in Disease

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Ongoing Clinical Trials for Lymphoma

This article provides detailed information about 9 ongoing clinical trials for lymphoma, a type of cancer affecting the lymphatic system. These trials are investigating new treatment approaches, imaging techniques, and medication combinations across multiple countries in Europe. Trials are currently being conducted in Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, and Sweden.

Clinical trial locations

Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas

This trial is testing a new imaging approach for patients with various cancers, including lymphomas. The study combines two advanced imaging techniques: Magnetic Resonance Spectroscopy using hyperpolarized pyruvate and PET scanning using Fluor-18-FDG. The main goal is to better understand how tumors use energy and nutrients, which could lead to improved cancer detection and monitoring methods.

Main inclusion criteria: Participants must be adults aged 18 or older with a confirmed diagnosis of breast cancer, neuroendocrine neoplasm, lymphoma, or sarcoma. The tumor must be at least 1.5 centimeters in size.

Main exclusion criteria: The study excludes people under 18 or over 65 years old, those with claustrophobia or metal implants incompatible with MRI, pregnant or breastfeeding women, patients with severe kidney dysfunction, and those unable to lie still in the scanner for up to 60 minutes.

Investigational substances: The trial uses hyperpolarized [1-13C]pyruvate for MR spectroscopy and 18F-FDG for PET imaging. These are imaging agents rather than treatments, designed to visualize how tumors process different nutrients. Both substances are administered through intravenous injection during a single combined PET/MR scanning session.

Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

This trial evaluates a treatment for aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous therapy. The study explores MEN1703, available in capsule form, both alone and in combination with glofitamab, which is given through intravenous infusion. The research is divided into parts focusing first on safety and tolerability, then on the treatments’ ability to fight the cancer.

Main inclusion criteria: Participants must be at least 18 years old with adequate organ function and an ECOG Performance Status of 0, 1, or 2. They must have a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma that has relapsed or is refractory after at least two prior lines of systemic treatment, with at least one measurable disease site.

Main exclusion criteria: The trial excludes patients with cancers other than the specified type, those under 18 or over 65 years old, patients unable to lie still in the PET/MR scanner for extended periods, and those with severe kidney or liver disease.

Investigational drugs: MEN1703 is being tested alone and with glofitamab. The combination aims to enhance the immune system’s ability to target and destroy cancer cells. Glofitamab is designed to help the immune system recognize and attack malignant B-cells.

Study of OSE-279 and OSE2101 Drug Combination for Patients with Advanced Solid Tumors, Lymphomas, or Metastatic Non-Small Cell Lung Cancer

This trial investigates the combination of OSE-279, a PD-1 blocking monoclonal antibody, and TEDOPI, a cancer vaccine. The study is divided into three parts: Part A determines the best dose of OSE-279 in patients with advanced solid tumors or lymphomas; Part B evaluates the safety and tolerability of the combination in patients with metastatic non-small cell lung cancer who have the HLA-A2 genetic marker; and Part C compares the effectiveness of the combination treatment to OSE-279 alone.

Main inclusion criteria: Participants must be adults 18 or older who have signed informed consent and are willing to follow the study schedule. For Part A, patients must have advanced solid tumors or lymphomas with no standard treatment options available. For Parts B and C, patients must have Stage IV non-small cell lung cancer without certain genetic changes, with at least one measurable tumor, and must not have received previous systemic treatment for metastatic disease.

Main exclusion criteria: The trial excludes patients without HLA-A2 positive phenotype, those without metastatic non-small cell lung cancer or advanced solid tumors/lymphomas as specified, patients outside the specified age range, and those unable to follow study procedures.

Investigational drugs: OSE-279 blocks PD-1, helping the immune system recognize and attack cancer cells. OSE2101 is a cancer vaccine that stimulates the immune system to target and destroy tumor cells. The combination is designed to enhance the immune response against various cancers.

Study of Pembrolizumab for Children with Advanced Melanoma or PD-L1 Positive Solid Tumors and Lymphoma

This trial studies pembrolizumab in children with advanced melanoma, PD-L1 positive solid tumors, or lymphomas that have returned or are not responding to treatment. The medication is delivered as an intravenous infusion. The study aims to understand how safe pembrolizumab is for children and how well it works against these cancers, including those with high tumor mutational burden.

Main inclusion criteria: Participants must be between 6 months and less than 18 years old with adequate organ function and a Lansky Play Scale score of 50 or higher (if 6 months to 16 years) or Karnofsky score of 50 or higher (if older than 16). They must have advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumor or lymphoma that cannot be cured, with at least one measurable disease site. Female participants of childbearing potential must have a negative pregnancy test within 72 hours before the first dose.

Main exclusion criteria: The study excludes patients with cancer types different from those specified, those not between 6 months and 18 years old, patients whose cancer has not relapsed or is not resistant to treatment, and those unable to tolerate the study medication.

Investigational drug: Pembrolizumab is an immunotherapy that works by blocking a protein called PD-1 on immune cells, helping the body’s immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

Study of Tulmimetostat (CPI-0209) for Patients with Advanced Solid Tumors and Lymphomas

This trial examines CPI-0209, taken orally as a film-coated tablet, in patients with advanced solid tumors and lymphomas including urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, malignant pleural or peritoneal mesothelioma, and metastatic castration-resistant prostate cancer. Phase 1 focuses on finding the maximum tolerated dose, while Phase 2 evaluates how well the medication works in shrinking or controlling tumors.

Main inclusion criteria: Participants must be at least 18 years old and agree to use effective birth control. They must have advanced or metastatic tumors that have returned or worsened after standard treatment, or disease with no standard effective treatment available. Patients must have a life expectancy of at least 12 weeks, provide tumor samples for testing, have adequate bone marrow, kidney, and liver function, and a good performance status allowing daily activities.

Main exclusion criteria: The study excludes patients who have not fully recovered from previous treatments, those with serious health conditions that could interfere, pregnant or breastfeeding women, patients with another cancer within the last 5 years (except certain early-stage cancers), those currently in another trial, patients with active infections requiring treatment, and those with certain heart conditions or uncontrolled high blood pressure.

Investigational drug: CPI-0209 is being studied to determine the highest tolerable dose and its effectiveness in reducing or controlling tumor growth. It works by inhibiting specific proteins involved in cancer cell growth and survival.

Study on the Effectiveness of Rituximab and Drug Combination for Patients with High-Risk Aggressive B-Cell Lymphoma

This trial evaluates the R-Hyper-CVAD/R-MA treatment regimen for high-risk aggressive B-cell lymphomas. The treatment involves a combination of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, methotrexate, cytarabine, etoposide, prednisolone, and dexamethasone. These medications are administered through various forms including infusions, injections, and oral tablets. The study assesses how well this treatment works and monitors participants closely for safety and effectiveness.

Main inclusion criteria: Participants must provide written informed consent and be between 18 and 64 years old. They should be eligible to receive at least 4 courses of R-Hyper-CVAD/R-MA based on overall health, age, social situation, and lymphoma status. Patients must have untreated aggressive B-cell lymphoma meeting high-risk criteria. Women of childbearing potential must use effective birth control during treatment and for six months after, and sexually active males must use condoms during and for six months after treatment.

Main exclusion criteria: The study excludes patients with cancers other than the specified type, those younger than 18, vulnerable populations unable to make decisions independently, and those unable to follow study procedures or take medication as required.

Investigational drugs: The combination includes rituximab to help the immune system target cancer cells, cyclophosphamide to slow cancer cell growth, vincristine and doxorubicin to interfere with cancer cell division, methotrexate and cytarabine to stop cancer cell growth, and dexamethasone to reduce inflammation and kill cancer cells.

Study on Heparin Sodium and Sodium Chloride for Patients with Lymphoma or Myeloma Undergoing Stem Cell Collection

This trial investigates whether a single dose of heparin given before stem cell collection can increase the number of stem cells harvested from patients with lymphoma or myeloma. Stem cells are crucial for certain cancer treatments. The study compares patients receiving heparin to those receiving a placebo before the collection procedure.

Main inclusion criteria: Participants must have been diagnosed with myeloma or lymphoma and be scheduled for autologous peripheral stem cell harvest at Karolinska University Hospital. They must have provided written consent, be 18 years or older, with stem cell harvest starting on monitoring day 1 or 2, and weigh between 50 and 100 kg.

Main exclusion criteria: The study excludes patients with myeloma or lymphoma not meeting the specified criteria.

Investigational drug: Heparin is administered as a single intravenous dose before stem cell collection. The study examines whether it can improve the efficiency of stem cell harvesting, which is important for subsequent treatment steps.

Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

This trial studies lutetium Lu 177 edotreotide, a targeted radiopharmaceutical therapy, in children with somatostatin receptor-positive solid tumors or lymphomas. These tumors display specific markers that the treatment can target. An arginine-lysine solution is also used to protect the kidneys during treatment. The study aims to determine the appropriate dose for children based on safety and how the treatment is processed by the body.

Main inclusion criteria: Children must be at least 2 years old and younger than 18 with a confirmed diagnosis of an SSTR-positive tumor that has returned or not responded to at least one previous treatment. They must have a Karnofsky score of 50% or higher (if older than 16) or Lansky score of 50% or higher (if 16 or younger). Patients must have recovered from previous treatment side effects except for stable conditions. Those with previous anthracyclines or chest radiation must have a heart ejection fraction of 55% or higher. Tumors must show SSTR expression confirmed by immunohistochemistry and show appropriate uptake on scanning within two months before joining.

Main exclusion criteria: The study excludes patients not at least two years old, those without SSTR-positive tumors or lymphomas, patients who have not tried previous treatments, those unable to safely receive the study treatment, pregnant or breastfeeding patients, those with interfering medical conditions, and those unable to follow study procedures.

Investigational drug: Lutetium Lu 177 Edotreotide delivers radiation directly to tumor cells by binding to somatostatin receptors, minimizing damage to surrounding healthy tissue. It is administered through intravenous infusion over several treatment cycles.

Study of Valemetostat Tosylate for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

This trial investigates valemetostat tosylate, taken as a film-coated tablet, for patients with peripheral T-cell lymphoma that has returned after treatment or has not responded to previous treatments. The study follows a single-arm design where all participants receive the same medication as monotherapy. Regular assessments track participants’ health status and tumor response to treatment.

Main inclusion criteria: Participants must provide signed informed consent and be at least 18 years old or the legal adult age in their area. They must have an ECOG performance status of 0, 1, or 2, allowing them to perform daily activities. Patients must have confirmed peripheral T-cell lymphoma diagnosis (specific subtypes listed) or adult T-cell leukemia/lymphoma with positive anti-HTLV-1 antibody test. They must have at least one measurable tumor, disease that has not responded to or returned after at least one previous treatment, and be considered not suitable for hematopoietic cell transplant.

Main exclusion criteria: The study excludes patients with different cancer types than specified, those who have not experienced cancer return or worsening, patients outside the specified age range, those unable to follow procedures or take medication as required, pregnant or breastfeeding women, patients in another trial simultaneously, those recovering from recent major surgery, patients with allergic reactions to the study medication, and those with uncontrolled infections.

Investigational drug: Valemetostat tosylate works by inhibiting certain enzymes involved in cancer cell growth and survival, thereby slowing or stopping disease progression. It is being studied for its effectiveness in shrinking tumors and its safety profile.

Summary

These nine ongoing clinical trials represent diverse approaches to treating lymphoma across Europe. The trials span multiple countries, with France and Spain showing the highest concentration of studies, each hosting six trials. Italy follows with four trials, while Sweden participates in three. Other countries including Belgium, Denmark, Germany, Netherlands, Poland, and Portugal each contribute to one or more studies.

The trials encompass different treatment strategies, from innovative imaging techniques to novel drug combinations and immunotherapies. Several studies focus on relapsed or refractory disease, reflecting the need for new treatment options when standard therapies fail. Notably, two trials specifically target pediatric populations, addressing the particular needs of children with lymphoma and related cancers.

The research includes various lymphoma subtypes, with particular emphasis on aggressive B-cell lymphomas and peripheral T-cell lymphomas. Several trials investigate immune checkpoint inhibitors and combination therapies, representing current trends in cancer treatment development. Some studies also explore targeted radiopharmaceutical therapies and advanced imaging methods that could improve both diagnosis and treatment monitoring.

Ongoing Clinical Trials on Lymphoma

  • Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

    Recruiting

    1 1 1
    France Italy Spain
  • Study of OSE-279 and OSE2101 Drug Combination for Patients with Advanced Solid Tumors, Lymphomas, or Metastatic Non-Small Cell Lung Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Belgium France Spain
  • Study on the Effectiveness of Rituximab and Drug Combination for Patients with High-Risk Aggressive B-Cell Lymphoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Sweden
  • Study on Heparin Sodium and Sodium Chloride for Patients with Lymphoma or Myeloma Undergoing Stem Cell Collection

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Sweden
  • Study of Valemetostat Tosylate for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

    Not recruiting

    2 1 1
    Investigated diseases:
    France Italy Spain