Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)
This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This study is targeting pediatric and young adult patients aged 1-29 years with CD19+ B cell malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome with conventional chemotherapy, in high-risk first relapse, or and in second or greater relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of huCART19 in patients with poor response to prior B cell directed engineered cell therapy.
NCT03792633 — Acute Lymphoid Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoid-leukemia/NCT03792633/
Phase I/II Study to Evaluate Treatment of Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T Adoptive Cellular Immunotherapy With CAR-T Cells Targeting CD38
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. CD38 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD38. This is a phase 1/2 study designed to determine the safety of the gene-edited specificity CD38 CAR-T cells and the feasibility of making enough to treat patients with relapsed B-cell acute lymphoblastic leukemia after CD19 CAR-T adoptive cellular immunotherapy.
NCT03754764 — Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI
Status: Recruiting
http://inclinicaltrials.com/relapsed-b-cell-acute-lymphoblastic-leukemia-after-cd19-car-t-aci/NCT03754764/
Phase I Trial of Ribociclib in Combination With Everolimus and Dexamethasone in Children and Young Adults With Relapsed Acute Lymphoblastic Leukemia
This research study is evaluating a drug called ribociclib (LEE011) given in combination with everolimus and other standard of care chemotherapy drugs as a possible treatment for relapsed or refractory ALL. The names of the drugs involved in this study are: - ribociclib - everolimus - dexamethasone
NCT03740334 — Acute Lymphoblastic Leukemia ALL
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-all/NCT03740334/
A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
NCT03739814 — Recurrent B Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/recurrent-b-acute-lymphoblastic-leukemia/NCT03739814/
Retrospective Study of Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
Background: Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. It occurs when a bone marrow cell develops errors in its DNA. Certain tests are used to help detect the disease. But the results of these tests often disagree. Researchers want to review the results of tests of bone marrow and cerebrospinal fluid (CSF) from people with ALL. They want to try to find the best ways to detect the disease. Objective: To compare results of certain bone marrow and CSF tests for detecting ALL, in order to see how much and how often the results disagreed. Eligibility: Children and young adults with ALL or lymphoblastic lymphoma who were enrolled in certain previous studies and consented for their data to be used. Design: Investigators will review participants medical records. They will collect data like the participant s gender, age, and when their tests were done. They will also collect results from tests like: Bone marrow tests Flow cytometry tests Imaging CSF cell count All of the stored data will be labeled by a code that only the study team at the research site can link to the participant. Data will be stored in password protected computers. ...
NCT03627208 — Leukemia, Lymphoblastic, Acute
Status: Completed
http://inclinicaltrials.com/leukemia-lymphoblastic-acute/NCT03627208/
Effect of Prophylactic Tyrosine Kinase Inhibitor Therapy Post-transplants on Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Undergoing Allo-HSCT With Minimal Residual Disease Positive Pre-transplants
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ ALL. Moreover, our result suggested that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.
NCT03624530 — Minimal Residual Disease
Status: Recruiting
http://inclinicaltrials.com/minimal-residual-disease/NCT03624530/
Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals
The purpose of this study is to determine if adult survivors of childhood Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLife (St. Jude Life) protocol are at increased risk for postural control deficits compared to individuals with no cancer history. All participants will be assessed for their ability to maintain an upright posture, walk at their usual speed, and to tandem walk, all while engaged in a cognitive task. Primary Objective To compare changes in postural control in ALL survivors to changes in postural control in healthy controls, matched on age- and sex- in simple versus complex standing and walking activities (complex: standing or walking with added cognitive load). Secondary Objective To identify demographic and performance related risk factors for decreased postural control during complex standing or walking activities in survivors and controls and to evaluate associations between treatment and the changes in postural control during complex activities among survivors.
NCT03581045 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT03581045/
SJCAR19: A Phase I/II Study Evaluating SJCAR19 (CD19-Specific CAR Engineered Autologous T-Cells) in Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of the body's basic disease fighters: antibodies and T Cells. For this type of therapy, peripheral (circulating) immune cells are collected and then undergo a manufacturing process to engineer them to more effectively kill cancer cells. The SJCAR19 product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: 1. The largest dose of SJCAR19 that is safe to give, 2. How long SJCAR19 cells last in the body, 3. The side effects of SJCAR19, and 4. Whether or not treatment with SJCAR19 is effective in treating people with refractory or relapsed ALL.
NCT03573700 — Acute Lymphoblastic Leukemia, in Relapse
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-in-relapse/NCT03573700/
Mitochondrial Cofactors for the Treatment of Hyperbilirubinemia Due to PEG-Asparaginase and or Inotuzumab Ozogamicin in Patients With Acute Lymphoblastic Leukemia (ALL)
This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. Vitamin B complex is a dietary supplement that may be used for patients with nutritional deficiencies. Giving levocarnitine and vitamin B complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.
NCT03564678 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT03564678/
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Target Total Therapy for Adult Ph-like Acute Lymphoblastic Leukemia
Ph-like ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-arm, multi-site trial PDT-Ph-like-ALL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide and dasatinib for adult Ph-like ALL.
NCT03564470 — Leukemia
Status: Recruiting
http://inclinicaltrials.com/leukemia/NCT03564470/