Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Philadelphia Chromosome-negative (Ph-) B-cell Acute Lymphoblastic Leukemia (B-ALL): a Single-arm, Multicenter Study
This study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL).
NCT05657652 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05657652/
A Early Phase 1 Clinical Trial To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
NCT05651191 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT05651191/
A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children and adolescents who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll approximately 75 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
NCT05622682 — Acute Lymphoblastic Leukemia, Pediatric
Status: Enrolling by invitation
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-pediatric/NCT05622682/
A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.
NCT05602194 — Lymphoblastic Lymphoma
Status: Recruiting
http://inclinicaltrials.com/lymphoblastic-lymphoma/NCT05602194/
A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment. This retrospective Study enroll adult patients who: - were CD22 positive (a molecule in the body that stops the over activity of the immune system) - Received only InO for the treatment of B-cell ALL that occurred again after the last treatment - were Philadelphia chromosome positive (which occurs because of changes in genes) - failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division). The patient data except their personal details are collected from a hospital based electronic medical record in India. In this study the effectiveness and safety of InO will be studied after it was released to the market. To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India: - in whom the disease occurred again - or those who never showed any improvement to earlier treatments - now being treated with InO alone Around 55 patients who have taken InO are likely to be enrolled in the study. Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.
NCT05597085 — Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/adult-relapsed-refractory-b-cell-acute-lymphoblastic-leukemia/NCT05597085/
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial
The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.
NCT05594784 — Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/philadelphia-chromosome-positive-acute-lymphoblastic-leukemia/NCT05594784/
Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in Refractory/Relapsed Acute Lymphoblastic Leukemia
To explore the efficiency and safety of CLAG regimen in R/R ALL
NCT05578378 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05578378/
A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia
This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) Bridging Hematopoietic Stem Cell Transplantation in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).
NCT05576181 — Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited
Status: Not yet recruiting
http://inclinicaltrials.com/allogeneic-car-t-protein-sequestration-non-gene-edited/NCT05576181/
A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
NCT05559450 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT05559450/
The Safety and Clinical Efficacy of Dasatinib Plus Human CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Subjects With Ph-positive Acute Lymphoblastic Leukemia
To evaluate the safety and efficacy of Dasatinib plus CD19/CD22 Bispecific CAR-T for the treatment of elderly Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given Dasatinib plus VP chemotherapy for induction treatment,if a hematologic complete remission was observed then a lymphocyte collection will be administrated to patients. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells
NCT05523661 — Dasatinib
Status: Recruiting
http://inclinicaltrials.com/dasatinib/NCT05523661/