Trial · NCT02879695
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events | Up to 5.5 years | Defined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported. |
| Primary | Number of Participants With Dose Limiting Toxicities | Up to 5.5 years | Maximum tolerated dose was determined by the absence of dose limiting toxicity in each patient assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Dose Limiting Toxicities were evaluated during treatment; therefore, the time frame is from the first participant starting treatment to the last participant completing treatment. |
| Secondary | Count of Participants Responders With Minimal Residual Disease | Up to 5.5 years | Will be assessed by flow cytometry. Participants who have a clinical response (responders) were evaluated for minimal residual disease negative versus minimal residual disease positive. These are the participants with remission as provided in the Secondary Outcome #4. |
| Secondary | Number of Participants Achieving Remission | Up to 5.5 years | Remission includes participants achieving complete remission or complete remission with incomplete blood count recovery by standard leukemia outcome measures. |
| Secondary | Duration of Response | Up to 5.5 years | 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 after treatment |
| Secondary | Overall Survival | Up to 5.5 years | Determined from the first day of treatment on the study until death or last known follow up, assessed up to 2 years after completing treatment. |
| Other | Changes in Absolute Lymphocyte Count | About 1 year | To examine changes in absolute lymphocyte count before and after blinatumomab and immune checkpoint inhibitor(s) therapy in both peripheral blood and the bone marrow microenvironment. Timeframe is based on duration of treatment. |
| Other | Changes in Distribution of T Cell Subsets and Differentiation Status, Natural Killer (NK) Cells, and B Cells | About 1 year | 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. Timeframe based on duration of treatment. |
| Other | Changes in T Cell Co-signaling Receptors Expression | About 1 year | To explore changes in T cell co-signaling receptors expression in defined T cell subpopulations and their canonic transcription factor expression in both peripheral blood and bone marrow before and post-blinatumomab, and immune checkpoint inhibitor(s) therapy. Time frame based on duration of treatment. |
| Other | Changes in Expression of Co-signaling Molecules on Leukemia Blasts | About 1 year | To examine changes in expression of co-signaling molecules on leukemia blasts (CD10+/CD19+/CD34+) before and after treatment with blinatumomab and checkpoint inhibitors. Time frame based on the duration of treatment. |
| Other | Changes in Cytokines Levels in Serum | About 1 year | To examine the serum levels of cytokines before and after treatment with blinatumomab and checkpoint inhibitors, including the levels of sCTLA-4. Time frame based on duration of treatment. |
| Other | Characterization of T Cell Transcriptional Signature | About 1 year | To perform immune profiling of T cell repertoire and characterize T cell transcriptional signature before and after treatment. Time frame based on duration of treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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