Clinical Research Directory

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.

Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies

To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.

mNGS for IFD in Patients With Hematological Malignancies

Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.

Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies

The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant

The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT). The main questions it aims to answer are: Does oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety? Participants will: Receive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT. Undergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care. Have regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD). Provide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.

Risk Prediction Scores for Cardiotoxicity in Cancer Patients Treated With Cardiotoxic Anticancer Therapies in Europe

Cancer management has undergone major advances over the past 30 years. Several anticancer therapies are now highly effective, allowing many cancers to become chronic diseases through sequential lines of treatment. However, these therapies may be associated with severe cardiovascular adverse events. It is therefore essential to better understand the factors that determine, for a given patient and a given anticancer therapy, the occurrence of cardiovascular toxicity, and ideally to predict which patients are at highest risk. The 2022 ESC Cardio-Oncology Guidelines strongly recommend risk stratification prior to the initiation of cardiotoxic anticancer therapies. Current recommendations suggest the use of risk scores known as "HFA-ICOS" scores. However: Not all cardiotoxic anticancer therapies currently have an associated risk score; Existing scores are derived from small retrospective or prospective cohorts (typically fewer than 100 patients), and most have not undergone rigorous validation, leaving considerable room for improvement. The EU-CARTOX-SCORES protocol aims to develop new prediction scores for cardiotoxicity occurring within the first year after initiation of cardiotoxic anticancer therapies. This protocol is innovative through the integration of artificial intelligence and/or machine learning approaches alongside conventional statistical methods. These models will be interfaced with a dedicated cardio-oncology digital platform (CardioOncoPilot), currently being deployed across the European Union, ensuring standardized and high-quality data collection within routine clinical care. This is a prospective, multicenter, observational study designed as a European cardio-oncology registry, involving all European cardiologists using the platform in routine practice. The inclusion period will last 3 years, with a 12-month follow-up for each patient. At the time of data extraction, all available cases recorded in the CardioOncoPilot platform will be analyzed. Overall, it is anticipated that between 1,000 and 5,000 patients across Europe will be included by the end of 2027. These patients will be managed in cardio-oncology clinics as part of routine care during treatment with cardiotoxic anticancer therapies, with follow-up conducted at the same center throughout the study. The primary endpoint will be the occurrence of cardiotoxicity as defined by the 2022 ESC Guidelines. Additionally, the performance of newly developed prediction models will be compared with existing HFA-ICOS risk scores (when available) in the same patient population. Patients will be followed according to routine clinical practice and in accordance with the 2022 ESC Cardio-Oncology Guidelines, which recommend both a baseline pre-treatment assessment and a follow-up evaluation at 1 year, regardless of the type of cardiotoxic therapy. Patient management will not be modified by the study. This research will consist solely of secondary use of data collected during routine care. Investigators anticipate that this study will significantly improve prognostic risk stratification tools in patients treated with cardiotoxic anticancer therapies, thereby enhancing identification of those at highest risk of clinically relevant cardiovascular adverse events during follow-up. This project will be conducted in collaboration with the ESC Council of Cardio-Oncology, ensuring optimal dissemination through appropriate scientific channels. The developed scores will be shared with the scientific community, particularly the European Society of Cardiology (ESC), with the aim of informing future guideline updates.

To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers

Cyclophosphamide is the name of a medicine given to prevent graft-versus-host-disease (GVHD) after half-matched transplant. This medicine is given on the 3rd and 4th day after stem cell transplant. The standard dose of this medicine is 50 mg per kg of the patient's weight given on the 3rd and the 4th day. However, using this medicine at this dose of 50 mg / kg for 2 days is associated with certain problems such as susceptibility to infections and delay in the recovery of the immune system after stem cell transplant. Therefore, several research groups across the world have tried to reduce the dose of cyclophosphamide that is used. These groups have tried reducing the dose from 50 mg per kg to 25-40 mg per kg. These studies have shown that the reduced dose cyclophosphamide is equally effective in preventing GVHD. However, these studies are carried out on small numbers of patients and further studies are essential to confirm whether reduced dose of cyclophosphamide is equally effective. In this study, we will use cyclophosphamide at a lower dose (25 mg/kg x 2 days) and see if the lower dose results in equal efficacy but lesser toxicities This is a single-arm study. All participants will receive the same treatment; there is no comparison group. Participants will: Adults (age ≥18) undergoing haploidentical stem cell transplant for blood cancers Receive low-dose cyclophosphamide (25 mg/kg/day) on Day 3 and Day 4 after transplant Also receive standard GVHD preventive medicines (calcineurin inhibitor and mycophenolate) Undergo regular blood tests, immune system monitoring, and GVHD assessments Have immune cell and cytokine profiles analyzed through blood samples

Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion. Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).

Durvalumab and Tremelimumab for Pediatric Malignancies

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

Study of AZD9829 in CD123+ Hematological Malignancies

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.

Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.

Immunological Impact of a Post Cell Therapy Treatment With FLT3 Inhibitors

Allogeneic hematopoietic stem cell transplantation (aHSCT) is the only curative option for many hematological maligancies. The main cause of death following HSCT is the relapse of the original disease. Few strategies have been developed to prevent relapse after bone marrow transplantation. New prophylactic strategies are needed to decrease the relapse incidence without increasing the non-relapse mortality in the post-transplant area. Several drugs are currently being explored as maintenance in several AML subgroups such as FLT3 ITD/mutated AML. A specific group of AML patients display the FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (ITD) or mutation. These recurrent genetic abnormalities account for 30-35% of all AML patients. Because FLT3 is a tyrosine kinase, it can be targeted using tyrosine kinase inhibitors (TKI). Originally limited to first generation sorafenib and Midostaurin, the FLT3 TKI now include second generation Gilteritinib, crenolanib and quizartinib13. Because many FLT3 AML patients would relapse after aHSCT, the use of sorafenib, the only FLT3 TKI available at that time, in a post-transplant setting started to be evaluated. Sorafenib is a multi-kinase inhibitor that not only inhibit FLT3 but also the RAS, RAF, KIT, and the VEGF and platelet-derived growth factor receptor. Several retrospective trials reported the safety and efficiency of a sorafenib maintenance. In recent years, a mounting piece of evidence suggests that sorafenib may have an impact on several immune cells as T cell populations, dendritic cells, macrophages and myeloid-derived immunosuppressor cells (MDSC). Other more potent and more specific FLT3 inhibitors are currently under investigation both in combination with chemotherapy before transplantation and as post transplantation maintenance. In this line, crenolanib and Gilteritinib are two potent and more specific TKI that proved more effective than sorafenib in the treatment of FLT3 ITD/TKD relapsed, refractory AML patients. These drugs demonstrated a higher response rate in R/R patients. These two drugs are part of the future standard of care in FLT3 AML but their immunological impact has never been studied. At a time where cellular therapies (allogeneic stem cell transplantation but also CAR T cells) and targeted therapies are becoming the central point of cancer treatment, it appears mandatory to better understand the interactions between the two. The goal of our research project which covers fundamental and clinical aspects of AML post-transplant treatments is devoted to a better understanding of the impact of Gilteritinib on the immune cells in order to rationalize their use after aHSCT. A better characterization of the action of these drugs on the immune system is urgently needed to develop new prophylactic strategies which could decrease the relapse incidence without increasing the non-relapse mortality in the post-transplant area. This program is proposed for a period of 3 years, time necessary to perform all the in vitro and ex vivo approaches and to recruit a sufficient number of patients eligible for aHSCT.

Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for hematological malignancies. Nonetheless, poor graft function remains a life-threatening complication after allo-HSCT. Poor erythroid engraftment is associated with increased bleeding events and shorter survival. Current treatment methods such as epoetin or repeated red-cell transfusions are not effective for poor erythroid engraftment, with limited and transient responses. Retrospective studies suggested that luspatercept showed efficacy in patients with anemia post-transplantation or poor erythroid engraftment. However, there are no studies comparing luspatercept versus epoetin for the treatment of poor erythroid engraftment. Therefore, we conducted a randomized controlled study to compared the effect of luspatercept versus epoetin in treating poor erythroid engraftment for hematological malignancies.

Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies

Platelet transfusion refractoriness (PTR) is a common complication in patients with hematological malignancies. It not only prolongs the duration of platelet transfusion dependence and significantly increases the risk of bleeding, but is also strongly associated with graft failure and reduced survival after transplantation. HLA class I antibody-mediated alloimmunization is recognized as the most important immunological cause of PTR. HLA antibodies are directly secreted by plasma cells, which are derived from B cells. Therefore, targeting B cells to reduce antibody production is a crucial step in eliminating HLA antibodies. Bruton's tyrosine kinase (BTK) is expressed throughout B cell development from the pre-B cell stage to maturity and supports B cell development, maturation, survival, proliferation, and antibody production by acting as a downstream kinase in the B cell receptor signaling pathway. Bortezomib, a proteasome inhibitor, can selectively induce apoptosis in long-lived plasma cells. The investigators' preliminary exploratory use of a BTK inhibitor in the treatment of PTR with HLA antibodies significantly reduced the mean fluorescence intensity (MFI) of HLA antibodies, improved platelet transfusion outcomes, and demonstrated a favorable safety profile. Based on these findings, the investigators are conducting a prospective, multicenter, randomized controlled two-arm study to investigate the efficacy and safety of acalabrutinib and bortezomib in eliminating HLA antibodies in hematological malignancies patients with PTR.

Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered. Some of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called "molecular" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study. This research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA

A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005)

The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of oral nemtabrutinib in Chinese participants at least 18 years of age who have Relapsed/Refractory hematologic malignancies.

Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France

Integrative medicine promotes the incorporation of elements from complementary and alternative medicines (CAM) into patient care. These approaches are defined as treatments that are not routinely part of conventional medical care (1). CAM practices include osteopathy, acupuncture, aromatherapy, naturopathy, and various energy-based techniques, although their efficacy is not always well-established. Nevertheless, a meta-analysis on the use of CAM in the context of cancer reported a 40% prevalence of use in 2012 (2). Subsequently, a study conducted in France in 2015 revealed an 83% prevalence of CAM use across all types of cancer, underscoring the interest in these therapies (3). CAM is often employed to alleviate side effects of conventional treatments, such as fatigue, nausea, and vomiting. The 2015 French study primarily focused on solid tumors, with hematological malignancies representing only 2% of the cases, thereby limiting the assessment of CAM use in this context (3). Currently, there is no specific data evaluating the use of CAM among patients with hematological malignancies in France. Hematological malignancies, unlike solid tumors, are characterized by their diffuse nature, making their localization and treatment more challenging for patients to comprehend (4). Additionally, a qualitative study the investigators conducted on the spiritual needs of patients recently diagnosed with hematological malignancies identified CAM as an area of interest. Among the ten patients in the study, seven were using CAM and reported an improvement in their spiritual well-being, which is defined as the ability to integrate the meaning and purpose of life into their health experiences, through relationships with themselves, others, art, nature, or a higher entity. This aspect of CAM utilization was not explored in our previous study on the spiritual needs of patients, particularly in understanding their appeal and the motivations of patients to adopt them. Therefore, it appears crucial to explore this practice, which is known to be common among healthcare providers. Understanding these complementary care pathways would enable their safety (e.g., avoiding or informing about potential drug interactions) and foster the patient-provider relationship around a topic that is sometimes considered taboo (5). Ultimately, this would contribute to better supporting patients within a holistic care perspective.

Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology

This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.

The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting

The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting in Patients With Hematological Malignancies ABSTRACT Background: Chemotherapy is widely used in the treatment of hematological malignancies despite it has important and difficult side effects in patients. Chemotherapy induced nausea and vomiting are among the most common side effects in patients and antiemetic drugs may not be always curative. Purpose: This research aimed to determine the effectiveness of relaxation breathing exercise on managing chemotherapy induced nausea and vomiting in patients with hematological malignancies undergoing chemotherapy. Method: A randomized controlled trial design was conducted with a total of selected sixty eight patients with hematological malignancies (34 intervention and 34 control participants) undergoing chemotherapy hospitalized in the hematology clinic of a Training and Research Hospital. The intervention group implemented relaxation breathing exercise three times a day with a standard treatment protocol and the control group only received routine drug treatment for chemotherapy induced nausea and vomiting. Nausea and vomiting were assessed by filling Rhodes Index of Nausea Vomiting and Retching (RINVR) for the first six days after the start of the chemotherapy. Results: Data collection process ended. Data analysis process is in progress. Conclusion: In this study the effectiveness of relaxation breathing exercise on chemotherapy related nausea and vomiting will be examined in patients with hematological malignancies. Keywords: Relaxation breathing exercise; Hematological malignancies; Chemotherapy; Nausea and vomiting