Clinical Trials for Haematological Malignancy

There are currently 20 ongoing clinical trials investigating new treatments for haematological malignancies, including blood cancers such as leukemia, lymphoma, and multiple myeloma. These studies are testing various innovative therapies, including antibody-based treatments, cell therapies, and immune checkpoint inhibitors, across multiple European countries and beyond.

Clinical trial locations

Continued Treatment Study for Patients with Blood Cancers Using Tafasitamab

This study focuses on patients with blood cancers who have already been receiving tafasitamab in previous clinical trials and continue to benefit from the medication. The main goal is to provide ongoing treatment and monitor the long-term safety of tafasitamab in these patients.

Inclusion criteria: To participate, patients must be adults who are currently enrolled in a previous tafasitamab study and tolerating the treatment well at their prescribed dose. They must show a complete or partial response or stable disease and be following the rules of the previous study. Patients need to be willing to attend scheduled visits and follow the treatment plan. Both men and women can participate, including those from vulnerable populations who may need extra protection or care.

Exclusion criteria: Patients with certain types of blood cancers known as hematologic malignancies cannot participate. Those not within the specified age range or who are part of a vulnerable population requiring special protection are also excluded.

Focus of the trial: The study aims to ensure that patients who are benefiting from tafasitamab can continue receiving it safely. Researchers will monitor for any serious side effects and evaluate how patients respond to ongoing treatment. The study involves regular visits for treatment administration and health assessments, lasting until December 2027.

Investigational drug: Tafasitamab is a humanized monoclonal antibody administered through intravenous infusion. It targets a protein called CD19 found on the surface of cancer cells, helping the immune system recognize and destroy these cells. This medication is used to treat certain types of blood cancers.

Long-term Follow-up Study for Patients with Solid and Blood Cancers Treated with Brexucabtagene Autoleucel or Axicabtagene Ciloleucel

This trial monitors patients who have previously received gene-modified cell therapies known as Tecartus or Yescarta. The study aims to understand the long-term effects and potential late-onset side effects of these advanced treatments.

Inclusion criteria: Patients must have previously received an infusion of gene-modified cells in a Kite-sponsored study and completed the required follow-up assessments. They must not have withdrawn their consent or stopped participating in the previous study. Participants must sign an informed consent form and be willing to attend follow-up visits. The study is open to both males and females, including those from vulnerable populations.

Exclusion criteria: Patients with solid or hematological malignancies who have experienced serious side effects related to gene-modified cells, such as neurological disorders, autoimmune disorders, blood issues, serious infections, or new cancers, are excluded. Those with conditions related to certain viral infections or genetic changes caused by treatment, or who are not within the specified age range, cannot participate.

Focus of the trial: The study evaluates the incidence and severity of late-onset adverse effects that may include neurological, autoimmune, or blood-related disorders, serious infections, or secondary cancers. Researchers also assess the growth and development of pediatric and adolescent participants, as well as immune system recovery.

Investigational drug: Gene-modified cells are the focus of this therapy. These cells have been altered in a laboratory to enhance their ability to fight diseases such as certain types of cancer. The trial monitors the long-term effects of these modified cells on patients.

Long-term Safety Study of CRISPR CAR T Cell Therapy for Patients with Blood and Solid Cancers

This study evaluates the long-term safety of CRISPR CAR cellular therapy in patients with blood cancers and solid tumors. Participants have already received this advanced genetic therapy, and the study tracks any side effects and health outcomes over time.

Inclusion criteria: Patients must have already received CRISPR CAR cellular therapy, be able to understand and comply with study procedures, and sign a consent form. The study is open to both male and female patients with either blood-related cancers or solid tumors, and it does not specifically focus on vulnerable populations.

Exclusion criteria: Patients with hematologic malignancy or solid malignancy who are not within the specified age range or who are part of a vulnerable population are excluded.

Focus of the trial: The study monitors participants for adverse events related to CRISPR CAR cellular therapy, including serious side effects and those of special interest. It involves long-term follow-up to assess overall survival and duration of remission or response to therapy, with regular health evaluations continuing until August 2039.

Investigational drug: CRISPR CAR Cellular Therapy uses a patient’s own immune cells, modified in the laboratory using CRISPR technology. This modification helps the immune cells better recognize and attack cancer cells, enhancing the body’s natural ability to fight cancer.

Study of Fibrinogen Treatment for Bleeding in Patients with Blood Cancer and Low Platelet Count Who Do Not Respond to Platelet Transfusions

This trial tests whether adding human fibrinogen to platelet transfusions can improve blood clotting in patients with blood cancers who have low platelet counts and do not respond well to platelet transfusions alone.

Inclusion criteria: Patients must be at least 18 years old with a blood cancer requiring intensive chemotherapy or stem cell transplantation. They must have bleeding symptoms rated as grade 1 or higher, a condition where platelet transfusions are not working effectively, body weight between 38 and 78 kilograms, and a low platelet count that doesn’t improve sufficiently after transfusions. Both men and women can participate.

Exclusion criteria: Those under 18 or over 65 years old, with blood clotting disorders not related to blood cancer, known allergies to blood products or fibrinogen, active severe infection, severe liver disease, recent major surgery, pregnancy or breastfeeding, current participation in other trials, inability to provide consent, history of severe reactions to blood transfusions, presence of interfering antibodies, severe kidney disease requiring dialysis, active brain bleeding, or unstable heart condition are excluded.

Focus of the trial: The study aims to determine if combining fibrinogen with platelet transfusions can improve blood clotting measured by ROTEM tests. Researchers will track bleeding events and monitor for side effects while assessing the treatment’s effectiveness.

Investigational drugs: Fibrinogen is a blood-clotting protein given intravenously to help control bleeding when platelet transfusions alone are insufficient. Platelet transfusion involves giving platelets from donated blood to patients with low platelet counts due to chemotherapy.

Study of Posaconazole for Preventing Fungal Infections in Patients Receiving Stem Cell Transplants for Blood Cancer

This study examines how well posaconazole, an antifungal medication, prevents serious fungal infections in patients receiving stem cell transplants from partially matched donors.

Inclusion criteria: Patients must be 18 years or older with no maximum age limit, scheduled to receive a stem cell transplant for blood-related cancer or non-cancerous disease with high-risk criteria for fungal infection. These criteria include using an alternative donor, sequential conditioning, use of certain immune-suppressing drugs, or having received a previous stem cell transplant. Patients must provide written consent, have an acceptable performance status, negative tests for Hepatitis B, C, and HIV, and be affiliated with social security. Women of childbearing age need a negative pregnancy test and must use effective contraception during treatment and for 12 months after. Men must also use contraception during treatment and for 6 months after.

Exclusion criteria: Non-adults, those not due to receive an allograft for blood-related cancer, those without a close HLA match donor, and those not being treated in specific hematology departments are excluded.

Focus of the trial: The study determines how many patients have an effective level of posaconazole in their system after one week of treatment. It monitors adherence to medication, symptoms like nausea or vomiting, and evaluates the medication’s effectiveness in preventing fungal infections through regular health assessments.

Investigational drug: Posaconazole is an antifungal medication administered orally to prevent invasive fungal infections in high-risk patients undergoing stem cell transplantation.

Study of Tislelizumab, Pamiparib, and Ociperlimab in Patients with Advanced Solid Tumors and Blood Cancers

This study evaluates the long-term safety of investigational drugs including Tislelizumab, Pamiparib, and Ociperlimab in patients with advanced cancers who continue to benefit from treatment in a related parent study.

Inclusion criteria: Patients must be currently participating in a BeiGene-sponsored parent study, meet treatment criteria specified in that protocol, and be expected to continue benefiting from treatment. The first dose in this study must be received within the allowed break period from the parent study. Female patients of childbearing potential and their male partners must use highly effective birth control methods during the study and after the last dose. Male patients must avoid donating sperm during and after treatment. A signed informed consent form is required before enrollment.

Exclusion criteria: Patients with cancers other than solid tumors or hematological malignancies, those not within the specified age range, not part of the specific trial group, or considered part of a vulnerable population are excluded.

Focus of the trial: The study monitors the long-term safety by observing side effects, especially serious ones affecting vital organs, and tracks overall survival from the start of treatment in the parent study.

Investigational drugs: Tislelizumab is an immune checkpoint inhibitor that helps the immune system fight cancer by blocking a protein that stops immune cells from attacking cancer cells. Pamiparib interferes with cancer cells’ ability to repair their DNA, potentially leading to their death. Other investigational agents are also being tested for their benefits and safety.

Study on Enhanced GVH Prevention in Elderly Patients with Blood Cancer Using Rabbit Anti-Human Thymocyte Immunoglobulin During Stem Cell Transplantation

This trial tests whether a low dose of Thymoglobuline can effectively prevent graft-versus-host disease in older patients who have received a haploidentical stem cell transplant.

Inclusion criteria: Adults aged 60 or older, or aged 50-59 with other health issues indicated by a HCT-CI10 score of 3 or higher. Patients must have a blood cancer (but not myeloproliferative syndrome or myelodysplastic syndrome), have received a specific type of transplant within 35 days, tolerate standard GVH prevention treatment, have recovered from aplasia within 35 days, have signed informed consent, and be affiliated with social security. Both men and women can participate, including those from vulnerable populations.

Exclusion criteria: Individuals with haematological malignancies cannot participate. Participants must be within certain age ranges (categories 3 and 4), and both males and females are eligible. However, participants from vulnerable populations are not selected for this study.

Focus of the trial: The study evaluates the effectiveness of low-dose Thymoglobuline in preventing GVH disease in elderly patients. It monitors for acute and chronic GVH using specific classifications at various intervals post-transplant, assesses blood counts for immune cells, tracks infections and complications, and evaluates long-term outcomes including survival and quality of life.

Investigational drug: Anti-lymphocytic serum (ATG), specifically Thymoglobuline, is used to help prevent graft-versus-host disease by reducing immune system activity. A low dose is given after transplant when neutrophil levels start to recover.

Study on Fludarabine, Melphalan, and ATG for Patients with Blood Cancer Undergoing Reduced Intensity Stem Cell Transplantation

This study examines how patients are exposed to F-Ara-A, a component of Fludarabine, during a reduced intensity conditioning regimen before stem cell transplantation.

Inclusion criteria: Patients must be 18 years or older (though older patients may be included if fit), provide written informed consent, have tried standard treatments with disease that has returned or not responded, have specific blood cancers according to medical criteria, a life expectancy of at least 8 weeks, an ECOG Performance Status of 0 to 2, measurable disease, normal heart function, adequate liver and kidney function, a platelet count of at least 10 x 10⁹/L, be able to take oral medication, and have a negative pregnancy test for women of childbearing age. They must be undergoing a specific type of stem cell transplantation with certain medications and use specified drugs to prevent graft versus host disease. They must have an appropriate donor.

Exclusion criteria: Non-adults, those with other cancer types, pregnant or breastfeeding individuals, those with interfering medical conditions, current participants in another trial, those who had recent major surgery or are recovering from major illness are excluded.

Focus of the trial: The study monitors cumulative exposure to F-Ara-A and how it varies between patients. It examines factors like body weight and kidney function that might influence F-Ara-A levels and evaluates outcomes such as survival rates, blood cell count recovery, and immune system recovery.

Investigational drug: Fludarabine is a chemotherapy medication used as part of the conditioning process before stem cell transplant. It interferes with the growth of cancer cells, which are then destroyed by the body.

Study on Graft-Versus-Host Disease Prevention Using Cyclophosphamide and Methotrexate in Adults with Blood Cancer Undergoing Matched-Donor Transplant

This trial compares two different conditioning regimens before stem cell transplant to estimate the occurrence of graft-versus-host disease and improve outcomes for patients with blood cancers.

Inclusion criteria: Patients aged 18-70 years with negative tests for Hepatitis B, C, and HIV, social security affiliation, diagnosed with a hematologic malignancy requiring allogeneic stem cell transplantation with reduced intensity preparation, use of peripheral stem cell graft, a perfect HLA match donor (10/10), protocol consent, ECOG score of 2 or less, and specific birth control requirements for both men and women during and after treatment.

Exclusion criteria: Non-adults, those without appropriate HLA match or family/registry donors, those not treated at participating centers, inability to provide consent, pregnancy or breastfeeding, interfering medical conditions, previous failed transplantation, active uncontrolled infection, severe organ dysfunction, current participation in interfering trials, or inability to follow study procedures.

Focus of the trial: The study estimates the incidence of severe GVHD that does not respond to standard treatments and assesses factors like overall survival, disease-free survival, and occurrence of infections. It monitors how well donor cells are accepted and how the immune system recovers over time.

Investigational drugs: Cyclophosphamide is used to prevent graft-versus-host disease by suppressing the immune system. Methotrexate also helps suppress the immune system, working alongside cyclophosphamide to protect transplanted cells from being attacked.

Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

This study evaluates how effective and safe Nemtabrutinib is for treating various blood cancers including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter’s Transformation, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, and Waldenström’s Macroglobulinemia.

Inclusion criteria: Patients must have a confirmed diagnosis of one of the specified blood cancers, an ECOG performance status of 0 to 2, life expectancy of at least 3 months, ability to swallow and retain oral medication, adequate organ function, and meet specific requirements for males and females regarding contraception and reproductive restrictions. Those with Hepatitis B, C, or HIV must meet additional criteria. Patients must have measurable disease and provide a lymph node biopsy for analysis.

Exclusion criteria: Patients with cancers other than the specified types, those not within the specified age range, those unable to follow procedures, those with unsafe medical conditions, pregnant or breastfeeding individuals, recent participants in other trials, those with allergic reactions to study medication, active infections requiring treatment, serious heart conditions, or history of drug or alcohol abuse are excluded.

Focus of the trial: The study is divided into two parts focusing on understanding safety, tolerability, and effectiveness of Nemtabrutinib. It measures how well the medication works in treating different types of blood cancers, with some participants receiving a placebo for comparison.

Investigational drug: Nemtabrutinib is a medication in tablet form being studied for its potential to treat various blood cancers by targeting specific proteins in cancer cells to help stop their growth and spread.

Study on the Safety and Effectiveness of SMART101 for Patients Undergoing Stem Cell Transplantation for Blood Cancers

This trial tests SMART101, a cell therapy involving specially prepared allogeneic T-cell precursors, to improve outcomes in patients receiving stem cell transplants from partially matched donors.

Inclusion criteria: Patients must be at least 18 years old, have a confirmed hematological malignancy requiring allogeneic HSCT with an HLA-mismatched donor, provide written informed consent, have a Karnofsky index of 70% or higher, adequate heart, lung, liver, and kidney function, and meet specific contraception requirements for both men and women for specified periods after treatment.

Exclusion criteria: Those who have not undergone hematopoietic stem cell transplantation, not in age range 3-4 years, not part of the trial group, not male or female, or not considered part of a vulnerable population are excluded.

Focus of the trial: The study determines the best dose of SMART101 and assesses its safety and effectiveness in helping immune system recovery, particularly focusing on CD4+ T-cells. It monitors for unexpected side effects and measures immune system recovery over time.

Investigational drugs: SMART101 is a cell therapy designed to improve immune system recovery after stem cell transplant, particularly helping CD4+ T-cells grow back. Cyclophosphamide is given after transplant to help prevent graft-versus-host disease.

Summary

The 20 ongoing clinical trials for haematological malignancies represent a diverse range of innovative therapeutic approaches being tested across Europe and beyond. A notable concentration of trials is taking place in France, which hosts 10 or more studies, followed by significant activity in Italy, Spain, Germany, and other European nations. This distribution reflects strong research infrastructure and clinical trial networks in these countries.

The trials encompass several key therapeutic strategies. A significant number focus on antibody-based treatments such as tafasitamab, tislelizumab, and daratumumab combinations. Advanced cell therapies are prominently featured, including gene-modified CAR T-cell therapies and CRISPR-based cellular therapies, representing cutting-edge approaches to treating blood cancers. Several studies address complications of stem cell transplantation, particularly graft-versus-host disease prevention using various immunosuppressive strategies including cyclophosphamide, methotrexate, and anti-thymocyte globulin.

The trials include both adult and pediatric populations, with some specifically targeting elderly patients or vulnerable populations who require special consideration. Many studies are investigating treatments for relapsed or refractory disease, addressing the significant unmet need for patients who have not responded to standard therapies. The research spans various types of blood cancers including acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndromes.

These trials collectively aim to improve survival rates, reduce treatment-related complications, and enhance quality of life for patients with haematological malignancies. The studies will continue through the late 2020s, with some extending to 2038-2039, providing long-term safety and efficacy data that will be crucial for advancing treatment options in this field.

#1 Clinical Trials Search in Europe

Haematological malignancy – Trials in Disease

Clinical Trials for Haematological Malignancy

Clinical trial locations

Continued Treatment Study for Patients with Blood Cancers Using Tafasitamab

Long-term Follow-up Study for Patients with Solid and Blood Cancers Treated with Brexucabtagene Autoleucel or Axicabtagene Ciloleucel

Long-term Safety Study of CRISPR CAR T Cell Therapy for Patients with Blood and Solid Cancers

Study of Fibrinogen Treatment for Bleeding in Patients with Blood Cancer and Low Platelet Count Who Do Not Respond to Platelet Transfusions

Study of Posaconazole for Preventing Fungal Infections in Patients Receiving Stem Cell Transplants for Blood Cancer

Study of Tislelizumab, Pamiparib, and Ociperlimab in Patients with Advanced Solid Tumors and Blood Cancers

Study on Enhanced GVH Prevention in Elderly Patients with Blood Cancer Using Rabbit Anti-Human Thymocyte Immunoglobulin During Stem Cell Transplantation

Study on Fludarabine, Melphalan, and ATG for Patients with Blood Cancer Undergoing Reduced Intensity Stem Cell Transplantation

Study on Graft-Versus-Host Disease Prevention Using Cyclophosphamide and Methotrexate in Adults with Blood Cancer Undergoing Matched-Donor Transplant

Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

Study on the Safety and Effectiveness of SMART101 for Patients Undergoing Stem Cell Transplantation for Blood Cancers

Summary

Ongoing Clinical Trials on Haematological malignancy

Study Comparing High-Dose and Standard-Dose Inactivated Influenza Vaccines in Adults with Blood Cancer

Study on Fecal Microbiota Transplantation to Prevent Complications in Patients After Stem Cell Transplant for Blood Cancer

Study on the Safety and Effects of Karonudib for Patients with Advanced Leukemia, Lymphoma, and Multiple Myeloma

Long-term Safety Study of CRISPR CAR T Cell Therapy for Patients with Blood and Solid Cancers

Study on Enhanced GVH Prevention in Elderly Patients with Blood Cancer Using Rabbit Anti-Human Thymocyte Immunoglobulin During Stem Cell Transplantation

Long-term Follow-up Study for Patients with Solid and Blood Cancers Treated with Brexucabtagene Autoleucel or Axicabtagene Ciloleucel

Study of fludarabine phosphate in patients with blood cancer undergoing lymphodepletion before CAR-T cell therapy

Study of AZD2962 tablets alone and with other medications in patients with myelodysplastic syndromes and dysplastic chronic myelomonocytic leukemia

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Haematological malignancy – Trials in Disease

Clinical Trials for Haematological Malignancy

Clinical trial locations

Summary

Ongoing Clinical Trials on Haematological malignancy

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