SNPMiner Trials (Home Page)
Report for SNP rs4958351
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
NCT03150693 B Acute Lymphoblastic Leukemia Drug: Allopurinol Drug: Cytarabine Drug: Daunorubicin Hydrochloride Drug: Vincristine Sulfate Drug: Dexamethasone Drug: Pegylated L-Asparaginase Drug: Methotrexate Procedure: Bone Marrow Aspiration and Biopsy Drug: Cyclophosphamide Drug: Mercaptopurine Biological: Rituximab Drug: Doxorubicin Drug: Thioguanine Biological: Inotuzumab Ozogamicin Other: Laboratory Biomarker Analysis MeSH: Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO: Leukemia Lymphoid leukemia
V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population.
Primary Outcomes
Description: Will be compared using log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Measure: EFS Time: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 yearsSecondary Outcomes
Measure: DFS Time: Time from achievement of CR to the time of relapse and/or death, assessed up to 10 yearsDescription: Will be evaluated using Kaplan-Meier as well as Cox regression models.
Measure: OS Time: Time from randomization to the time of death due to any cause, assessed up to 10 yearsDescription: Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Measure: Proportion of patients who achieve CR or any response to induction therapy Time: Up to 10 yearsDescription: Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Measure: Overall induction response rates Time: Up to 10 yearsDescription: The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.
Measure: Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 Time: Up to 10 yearsDescription: Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Measure: Proportion of patients who go off treatment due to adverse reactions Time: Up to 10 yearsDescription: Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Measure: Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial Time: Up to 10 years