View clinical trials related to Hematologic Diseases.
Filter by:High-risk malignant hematological diseases refer to malignant hematological diseases, mainly include various types of leukemia, lymphoma, and multiple myeloma, with very poor prognoses, very short survival, and unsatisfactory outcomes. Chemotherapy, hypomethylating agents (HMA), radiotherapy, targeted therapy, immunotherapy, and hematopoietic stem cell transplantation (HSCT) are common treatments for high-risk malignant hematological diseases. Because of the multiple lines and long duration of exposure to chemotherapy drugs in patients with high-risk malignant hematological diseases, monotherapy is inefficient, and radiotherapy is used frequently as an adjunct treatment to HSCT. Conventional myeloablative conditioning regimens before HSCT are comprised of cyclophosphamide/total body irradiation (Cy/TBI) and busulfan/cyclophosphamide (Bu/Cy). The reduced-toxicity myeloablative conditioning regimen, FBC, is the combination of Bu, Cy, and fludarabine (Flu), which has a strong immunosuppressive effect to ensure the success of engraftment of donor cells. Compared to the conventional intensified chemotherapy regimens, HMA have certain advantages of efficacy and safety and are the first-line treatment options for patients with acute myeloid leukemia (AML). Although monotherapy improves survival rate, the response rate is low. What's more, it is difficult to achieve sustained remission and long-term benefits. The current research hotspots are HMA combined with chemotherapy, targeted drugs such as BCL-2 inhibitors, immunotherapy, and cell therapy. Targeted therapy and immunotherapy are effective, but show a high prevalence of relapse, heavy treatment burden, and the need for long-term maintenance. HSCT is an important therapy for the treatment of high-risk malignant hematological diseases, which could eliminate tumor cells through high-dose radiotherapy or chemotherapy, destroy the immune system of patients to prepare the engraftment of donor cells, and promote the reconstitution of hematopoiesis and immune recovery. HSCT has developed rapidly since the 1950s and has been performed in more than one million patients worldwide. HSCT is often the only definitive treatment available for patients with certain specific congenital or acquired diseases and is used in the treatment of many high-risk malignant hematological diseases. However, due to the strict criteria for HSCT, many patients do not have a matched donor. Since the first successful UCBT in a child with severe Fanconi anemia reported by Gluckman et al. in France in 1988, cord blood has been widely used as a graft source of hematopoietic stem cells for the treatment of hematological diseases. Cord blood is rich in hematopoietic stem cells, endothelial progenitor cells, mesenchymal stem cells, and other stem/progenitor cells, as well as natural killer cells, Treg cells, and other immune cells, which have strong self-renewal and proliferation ability and low immunogenicity. The hematologic growth factors produced by these cells could act on the formation of myeloid cells and granulocytes, which are beneficial to hematopoietic reconstruction and recovery. It contains a variety of cytokines such as thrombopoietin, erythropoietin, stem cell factor, and multi-class interleukins. Some cytokines such as stem cell factor, IL-6, and IL-11 are much higher in cord blood than in peripheral blood. The potential mechanism by which UCBT exerts its therapeutic effect in patients with hematological diseases is largely the result of the interaction of multiple growth factors and stem/progenitor cells with the organism. Compared with peripheral blood stem cell transplantation (PBST), UCBT has a higher transplantation rate, as cord blood stem cells are more primitive and purer than bone marrow stem cells. UCBT could be performed with four or more matches, and have a relatively lower rejection rate, lower relapse rate of malignant hematological diseases, and lower cumulative incidence of chronic graft-versus-host disease (GVHD), which greatly improves patient survival. Prof. Sun Zimin's team at Anhui Provincial Hospital was the first to use UCBT for the treatment of patients with AML and found that the cumulative incidence of chronic GVHD and relapse rate were significantly reduced. Based on the above, the TFBC regimen (TBI/Flu/Bu/Cy) combined with UCBT is safe and feasible for the treatment of patients with high-risk malignant hematological diseases, which has enormous potential to improve patient outcomes. Therefore, we designed this clinical study on the TFBC regimen combined with UCBT for the treatment of high-risk malignant hematological patients to observe the impact on the engraftment rate, relapse rate, the cumulative incidence of GVHD, and survival.
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory T-Acute Lymphoblastic Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.
This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.
This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.
This investigator-initiated, prospective, multicenter, open-label, randomized, controlled clinical study is designed to evaluate the clinical efficacy and safety of hetrombopag for promoting platelet engraftment after allo-HSCT in patients with hematological disease. After signing the informed consent form, the patients will enter the screening period (up to 14 days), and the qualified patients will be randomly selected into the experimental group and the control group according to the ratio of 1:1. Experimental group: After hematopoietic stem cell reinfusion, the patients begin to take hetrombopag orally 7.5mg/d, until the patients reach complete platelet response (CR, platelet count ≥ 50×109/L for 3 consecutive days without platelet transfusions for 7 consecutive days). The treatment will stop when patients accept 21 consecutive days of treatment or reach the discontinuation criteria. Control group: After hematopoietic stem cell transfusion, the patients will be only observed, and the observation during the treatment period will be ended after 30 days. Patients will continue to enter the follow-up period (+ 100 days after transplantation) and the survival follow-up period (1 year after transplantation) after the end of the treatment period.