Leukemia, Acute Lymphoblastic Clinical Trial
Official title:
Acute Lymphoblastic Leukemia Therapies Informed by Genomic Analyses
Verified date | January 2024 |
Source | New Mexico Cancer Care Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Previous work performed by University of New Mexico Comprehensive Cancer Center (UNMCCC) investigators has revealed previously unknown genomic mutations in children, adolescents, and young adults with high-risk B and T cell precursor acute lymphoblastic leukemia (ALL). Using genomic and next generation DNA sequencing technologies, these investigators revealed that 14% of children with high-risk ALL have "Philadelphia chromosome-like" ("Ph-like") ALL. Patients with this form of ALL were found to have a significantly increased risk of treatment failure and death. Further work revealed that there are more than 40 distinct gene rearrangements and fusions that can result in Ph-like ALL. Cell lines and human leukemic cells expressing some of these different gene fusions were sensitive to currently available drugs. This suggests that Ph-like ALL patients with these specific distinct gene fusions should be targeted in future clinical trials to be treated with appropriate therapy. Further work is also needed to identify other potentially targetable genetic alterations in ALL patients. Therefore, the goal of this study is to perform genomic screening of all newly diagnosed ALL patients seen at UNM and to use this information to enroll patients onto available National Clinical Trial Network (NCTN) clinical trials. If an appropriate NCTN trial is not available, best clinical management will be pursued.
Status | Terminated |
Enrollment | 21 |
Est. completion date | October 20, 2022 |
Est. primary completion date | March 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - New diagnosis of Acute Lymphoblastic Leukemia - No previous therapy, excluding emergency radiation, steroids or intrathecal cytarabine - Any age - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Previous therapy, excluding emergency radiation, steroids or intrathecal cytarabine - Not willing to obtain cancer care at the University of New Mexico |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
New Mexico Cancer Care Alliance |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ALL characterization: Low Density Array | Newly diagnosed ALL patients at UNMCCC will undergo Low Density Array (LDA) card screening (a gene expression classifier for Ph-like ALL) at initial diagnosis. The proportion of LDA status (positive vs. negative) and its 95% confidence interval will be calculated based on the exact binomial distribution. | 3 years | |
Primary | ALL characterization: Next Generation Sequencing | Newly diagnosed ALL patients at UNMCCC will undergo Next Generation Sequencing (NGS) at initial diagnosis. NGS (exomic and transcriptomic) of a sufficient read depth (500-700x) will be employed to detect clonal heterogeneity at diagnosis. Statistical analysis will be primarily descriptive (e.g. frequency (proportion) of various mutations will be calculated). | 3 years | |
Primary | ALL characterization: SNP analysis | Newly diagnosed ALL patients at UNMCCC will undergo Molecular Determination of Genetic Ancestry (using a panel of single nucleotide polymorphisms (SNPs)) at initial diagnosis. Statistical analysis will be primarily descriptive (e.g. frequency (proportion) of SNPs and genetic ancestry groups will be calculated) | 3 years | |
Secondary | Relationship of patient characteristics to trial enrollment | Genetic and molecular characterization as described for the Primary Outcome Measures will be summarized for patients who are enrolled on NCTN clinical trials and for those who are not enrolled on NCTN clinical trials. The two group comparisons (NCTN vs. non-NCTN) will be tested using non-parametric approach such as Wilcoxon sum rank test. | 3 years | |
Secondary | Relationship between race/ethnicity and outcome | Time-to-event data (such as Progression free survival (PFS), determined clinically) will be summarized using Kaplan-Meier curves along with log-rank test by the treatment groups as well as race/ethnicity determined through molecular assessment of genetic ancestry as described in Primary Outcome Measure 3. Multivariable Cox Proportional Hazards model will also be explored for PFS with treatment and/or ethnicity variables. | 3 years | |
Secondary | Feasibility of discovering molecular features in ALL with therapeutic relevance | Feasibility will be assessed by calculation of the following statistics: percent of patients who enrolled in NCTN trials, percent of patients with minimal residual disease (MRD) that are completely evaluated over time, percent of patients for whom molecularly characterization is feasible and informative over the treatment course. All estimated proportions will be accompanied by exact 95% confidence intervals | 3 years | |
Secondary | Minimal Residual Disease (MRD) evaluation | End-induction Minimal Residual Disease (MRD) will be performed using a Clinical Laboratory Improvement Amendments (CLIA)-approved flow-cytometric assay at the Children's Oncology Group University of Washington Reference Laboratory. Molecular MRD will also be determined using research-based deep sequencing. MRD repeatedly measured across time points will be summarized using descriptive statistics (bar graph for High vs. Low status). Associations between the MRD and the treatment groups (LAD Positive vs. LAD Negative for NCTN and Non-NCTN treatment groups), using the exact Pearson Chi-Square test with Monte Carlo simulation at each time point will be assessed. | 3 years |
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