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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02879695
Other study ID # NCI-2016-01300
Secondary ID NCI-2016-01300ET
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 25, 2017
Est. completion date September 6, 2024

Study information

Verified date September 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial studies the side effects and best dose of blinatumomab when given with nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+ precursor B-lymphoblastic leukemia that has come back after a period of improvement (relapsed) or has not responded to treatment (refractory). Immunotherapy with monoclonal antibodies, such as blinatumomab, nivolumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Description:

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Study Design


Related Conditions & MeSH terms

  • Acute Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrence
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Mixed Phenotype Acute Leukemia

Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Biological:
Blinatumomab
Given IV
Procedure:
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Biological:
Ipilimumab
Given IV
Nivolumab
Given IV

Locations

Country Name City State
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Yale University New Haven Connecticut
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in absolute lymphocyte count Baseline up to 2 years
Other Changes in distribution of T cell subsets and differentiation status, natural killer (NK) cells, and B cells Will be assessed by flow cytometry. The analyses of pre- and post-treatment peripheral blood and bone marrow specimens for immune parameters will be descriptive and graphical in nature. Data will be summarized for each patient group separately. Flow values at each time point will be summarized using geometric means and standard deviation. Differences in baseline values between patient subgroups will be explored using linear regression models. Baseline up to 2 years
Other Changes in T cell co-signaling receptors expression Baseline up to 2 years
Other Changes in expression of co-signaling molecules on leukemia blasts Will be summarized using descriptive statistics and either Wilcoxon rank sum tests or paired t tests, as appropriate for a single time point, or using the mixed effects linear regression models for simultaneously modelling data from multiple time points as previously described for analyzing the T cell population data. The changes in blasts in terms of expression of co-signaling molecules over time will be explored and summarize any correlation in the pattern of blast changes over time using the regression models and interaction tests. Up to 2 years
Other Changes in cytokines levels in serum Will be summarized using descriptive statistics and either Wilcoxon rank sum tests or paired t tests, as appropriate for a single time point, or using the mixed effects linear regression models previously described for simultaneously modelling data from multiple time points for the T cell population data. Baseline up to 2 years
Other Characterization of T cell transcriptional signature Expression levels will be summarized at pre-treatment and post-treatment using standard descriptive statistics. Differentially-expressed genes and corresponding fold-changes will be analyzed using standard statistics and through the use of Ingenuity pathway analysis. Up to 2 years
Primary Incidence of adverse events Incidence of adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events and toxicities will be tabulated and reported by type and grade for all dose levels of all treatment combinations and the proportions reported with exact 95% binomial confidence intervals. Up to 2 years
Primary Maximum tolerated dose Maximum tolerated dose will be defined as the maximum dose level in the absence of dose limiting toxicity in each patient assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum tolerated dose of the combination of blinatumomab plus nivolumab, and blinatumomab plus both nivolumab and ipilimumab will be determined in subjects with poor-risk, relapsed or refractory CD19+ Pre-B cell acute lymphoblastic leukemia or CD19+ mixed phenotype acute leukemia. Up to 2 years
Secondary Minimal residual disease Will be assessed by flow cytometry. For patients who have a clinical response, the frequency of minimal residual disease positive versus minimal residual disease negative responses will be reported by treatment arm and dose level for all patients on study. Up to 2 years
Secondary Anti-leukemia activity Up to 2 years
Secondary Complete remission The frequency distribution of responses, including complete remission, complete remission with incomplete blood count recovery or progressive disease will be reported by treatment arm and dose level for all patients on study and reported with exact 95% confidence intervals. Up to 2 years
Secondary Complete remission with incomplete blood count recovery The frequency distribution of responses, including complete remission, complete remission with incomplete blood count recovery or progressive disease will be reported by treatment arm and dose level for all patients on study and reported with exact 95% confidence intervals. Up to 2 years
Secondary Progressive disease The frequency distribution of responses, including complete remission, complete remission with incomplete blood count recovery or progressive disease will be reported by treatment arm and dose level for all patients on study and reported with exact 95% confidence intervals. Up to 2 years
Secondary Duration of response Will be analyzed using the Kaplan Meier method. A sensitivity analysis may be performed to evaluate duration of response while excluding patients who go on to have an allogeneic-hematopoietic stem cell transplantation. Time from measured response to progressive disease, death, or study end, assessed up to 2 years
Secondary Overall survival Will be measured using the Kaplan Meier method. From the first day of treatment on the study until death or last known follow up, assessed up to 2 years
See also
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