Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
NCT07372365 · Marginal Zone Lymphoma (MZL)
RecruitingThis study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib. Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment. This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSuzhou, Jiangsu, China
SponsorThe First Affiliated Hospital of Soochow University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL
NCT06509945 · Peripheral T Cell Lymphoma
RecruitingThis study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred. Donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose integrated with computed tomography (18F-FDG PET/CT) imaging will be performed every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus (CMV)and Epstein-Barr virus(EBV)reactivation within 1 year.
PhaseNA
TypeInterventional
Age18 Years – 70 Years
WhereShanghai, Shanghai Municipality, China
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
NCT06547528 · Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingA Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
PhasePhase 1
TypeInterventional
Age18 Years
WhereNagoya, Aichi-ken, Japan + 13 more
SponsorOno Pharmaceutical Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
NCT04957901 · Lymphoma
RecruitingThe next-generation sequencing (NGS) based on liquid biopsy has been an emerging technology to identify tumor-specific genetic aberrations in malignant tumors. The tumor tissue (FFPE) and plasma samples from the newly diagnosed pediatric lymphoma patients were collected and sequenced by 475 genes panel before, during and post treatment, to evaluate the significance of the ctDNA in efficacy prediction, predicting recurrence or mechanism of resistance to chemotherapy for pediatric lymphoma.
Phase—
TypeObservational
Age1 Year – 18 Years
WhereGuangzhou, China
SponsorSun Yat-sen University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
NCT05147467 · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingThe purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
PhasePhase 2
TypeInterventional
Age18 Years
WhereGuangzhou, Guangdong, China + 10 more
SponsorAscentage Pharma Group Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Venetoclax Basket Trial for High Risk Hematologic Malignancies
NCT05292664 · Myelodysplastic Syndromes, de Novo, Myelodysplastic Syndromes, Secondary, Myelodysplastic Syndromes, Previously Treated
RecruitingThis trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. * Venetoclax * Azacitidine * Cytarabine * Methotrexate * Hydrocortisone * Leucovorin * Dexamethasone * Vincristine * Doxorubicin * Dexrazoxane * Calaspargase pegol * Hydrocortisone
PhasePhase 1
TypeInterventional
Age1 Year – 40 Years
WhereSan Francisco, California, United States + 4 more
SponsorAndrew E. Place, MD
▾Tap for detailsClick for full details — eligibility, all locations, contacts Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal Type
NCT05477264 · Lymphoma
RecruitingThis clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK/T-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor. As a rationale for using PD-1 inhibitors in patients with NK/T-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK/T-cell lymphoma. Patients with low-stage NK/T-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience hematological and non-hematologic toxicities during treatment. Therefore, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK/T-cell lymphoma with low stage and International Prognostic Index.
PhasePhase 2
TypeInterventional
Age19 Years
WhereSeoul, South Korea
SponsorWon Seog Kim
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT05976763 · Mantle Cell Lymphoma
RecruitingThis phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
PhasePhase 3
TypeInterventional
Age60 Years
WhereLittle Rock, Arkansas, United States + 232 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma
NCT06946407 · Primary Central Nervous System Lymphoma (PCNSL), CNS Lymphoma Treatment
RecruitingHigh-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity. Consolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high. This study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.
PhaseNA
TypeInterventional
Age60 Years
WhereChangchun, China
SponsorFengYan Jin
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
NCT04365036 · NK/T Cell Lymphoma Nos
RecruitingThe purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereGuangzhou, Guangdong, China
SponsorSun Yat-sen University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
NCT05750706 · Acute Lymphoblastic Leukemia, Adult, Invasive Fungal Infections
RecruitingThe study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment
Phase—
TypeObservational
Age18 Years
WhereRome, Italy
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
▾Tap for detailsClick for full details — eligibility, all locations, contacts Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML
NCT06452732 · Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
RecruitingLeukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.
Phase—
TypeObservational
Age18 Years
WhereBeijing, Beijing Municipality, China + 1 more
SponsorPeking University People's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
NCT06875063 · Non-hodgkin Lymphoma, Refractory Lymphoma, Chimeric Antigen Receptor T-cell
RecruitingTo evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
PhasePhase 1
TypeInterventional
Age18 Years – 70 Years
WhereXiamen, Fujian, China
SponsorThe First Affiliated Hospital of Xiamen University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
NCT05921812 · Non-Hodgkin Lymphoma
RecruitingLymphomas are a fairly common malignancy accounting for approximately half of all newly diagnosed hematological neoplasms, and they comprise the sixth most common group of malignancies worldwide in both men and women, With marked geographic variations and affecting more males than females within the age range of 1 to 85 years but peaking within the second decades of life (Oluwasola AO et al., 2011, Roman E et al., 2011 and Jemal A et al., 2010) . Lymphomas have traditionally been classified as either Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) based on the presence or absence of the Reed-Sternberg (RS) cell on histology. (Fitzmaurice C et al., 2017). Non-Hodgkin's lymphoma (NHLs) comprise a wide class of lymphoid neoplasms that evolve from the clonal expansion of mature B, T and natural killer (NK) cells in different stages of development (Morton, L.M. et al., 2014 and Schmitz R et al., 2009). NHLs are the most prevalent hematopoietic neoplasms, accounting for approximately 4.3% of all cancer diagnoses (Sant, M. et al., 2010) , Of them, B cell NHL accounts for approximately 30% of all lymphoid neoplasms, followed by HL (8%) and T/NK neoplasms (5%) (Morton, L.M. et al., 2006). MicroRNAs (miRNAs) are a class of small, naturally occurring, noncoding and single-stranded RNA molecules (18, 22 nucleotides) that function as post-transcriptional regulators by directly cleaving target messenger RNA (mRNA) or translational repression (Bartel DP. Et al., 2004). The discovery of miRNA has exposed a new layer of gene expression regulation that affects many physiological and pathological processes of life (Lawrie CH. Et al., 2013). Many abnormal miRNA expression patterns are found in various human malignancies, and certain miRNAs play roles as oncogenes or tumor suppressors (Ling N et al., 2013). Certain miRNAs have been found to characterize various subtypes of NHL and have important roles in B-cell differentiation and lymphomagenesis (Zhang J et al., 2009, Malumbres R et al., 2009, Basso K et al., 2009 and Auer RL et al., 2011). Recently, many studies had shown that tumor cell-specific miRNAs were detectable in the plasma and serum of patients with cancer. Therefore, miRNAs may be served as good biomarkers for early detection, diagnosis, and follow up of patients with cancer (Cortez MA et al., 2012).
Phase—
TypeObservational
Age18 Years – 75 Years
WhereSohag, Egypt
SponsorSohag University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
NCT07473167 · Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL)
RecruitingThis is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.
PhasePhase 1 / Phase 2
TypeInterventional
Age19 Years
WhereSeoul, Seoul, South Korea
SponsorTICAROS Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CTD402 in T-ALL/LBL Patients
NCT07070219 · Acute Lymphocytic Leukemia Refractory, Lymphoma, Lymphoblastic
RecruitingThe goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate. Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL. Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WherePalo Alto, California, United States + 7 more
SponsorBIOHENG THERAPEUTICS US LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
NCT06977711 · Diffuse Large B-cell Lymphoma
RecruitingThis study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants. The aims are: 1. To assess the safety and how well the participants tolerate the treatment 2. Assess the response of the tumor to treatment to estimate complete response 3. Assess the response of the tumor to treatment to estimate progression-free survival
PhasePhase 1
TypeInterventional
Age18 Years
WhereSan Antonio, Texas, United States + 1 more
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts Co-administration of CART22-65s and huCART19 for B-ALL
NCT05674175 · B-cell Acute Lymphoblastic Leukemia, B Lineage Lymphoblastic Lymphoma
RecruitingThis study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).
PhasePhase 1 / Phase 2
TypeInterventional
Age29 Years
WherePhiladelphia, Pennsylvania, United States
SponsorStephan Grupp MD PhD
▾Tap for detailsClick for full details — eligibility, all locations, contacts Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia
NCT05869279 · B-cell NHL, CLL
RecruitingThis is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.
PhasePhase 1 / Phase 2
TypeInterventional
Age1 Year
WhereBergamo, BG, Italy
SponsorFondazione Matilde Tettamanti Menotti De Marchi Onlus
▾Tap for detailsClick for full details — eligibility, all locations, contacts CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
NCT06866873 · Lymphoma, B-Cell, Acute Lymphoblastic Leukemia, Pediatric
RecruitingThis study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
PhaseNA
TypeInterventional
Age1 Year – 17 Years
WhereHong Kong, Hong Kong
SponsorHong Kong Children's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts