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Report for Clinical Trial NCT03150693

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia

15 Interventions

Name: Allopurinol

Description: Given PO
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Cytarabine

Description: Given IT, IV, SC
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Daunorubicin Hydrochloride

Description: Given IV
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Vincristine Sulfate

Description: Given IV
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Dexamethasone

Description: Given PO or IV
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Pegylated L-Asparaginase

Description: Given IV
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Methotrexate

Description: Given IT, IV, PO
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Bone Marrow Aspiration and Biopsy

Description: Undergo bone marrow aspiration and biopsy
Type: Procedure
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Cyclophosphamide

Description: Given IV
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Mercaptopurine

Description: Given PO
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Rituximab

Description: Given IV
Type: Biological
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Doxorubicin

Description: Given IV
Type: Drug
Group Labels: 1

Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Thioguanine

Description: Given PO
Type: Drug
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Inotuzumab Ozogamicin

Description: Given IV
Type: Biological
Group Labels: 1

Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 2

Arm I (frontline chemotherapy) Arm II (frontline chemotherapy, inotuzumab ozogamicin)


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 years

Secondary Outcomes

Measure: DFS

Time: Time from achievement of CR to the time of relapse and/or death, assessed up to 10 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs4958351

V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population.



HPO Nodes


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