Trial · NCT02819804
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose-Limiting Toxicity (DLT) | Up to 28 days | Determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib, the MTD will be defined as the highest dose level at which ≤ 1 DLT occurs and will be assessed by the Common Terminology Criteria for Adverse Events version 4.03. |
| Secondary | Incidence of Adverse Events | Up to 28-days after the last dose | To evaluate the toxicity and safety of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL. Adverse events will be assessed by number, frequency, and severity and will be graded according to the NCI's common terminology criteria, version 4.03. |
| Secondary | Rate of Complete Hematologic Remission (CR) | At 84 days (3 cycles) | Determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib |
| Secondary | Rate of Molecular Remission | At 84 days (3 cycles) | Determine the rate of molecular remission after three cycles of nivolumab and dasatinib. |
| Secondary | Serum Level of Dasatinib | 24 hours after the start of cycle 1 and days 8, 15, and 22 prior to treatment during cycle 1 | The serum level of dasatinib will be measured at 24 hours after the start of cycle 1 and on days 8, 15, and 22 prior to treatment during cycle 1. |
| Secondary | Serum Level of Nivolumab | Days 8, 15, and 22 prior to treatment during cycle 1 | The serum level of nivolumab will be measured on days 8, 15, and 22 prior to treatment during cycle 1. |
| Secondary | PD1 Expression Levels and Saturation Assessed in the Peripheral Blood | Baseline to 28-days after the last dose | Peripheral blood will be evaluated to measure PD1 expression levels and saturation. |
| Secondary | PD1 Expression Levels and Saturation in Bone Marrow | Baseline to 28-days after the last dose | Bone marrow will be assessed to measure PD1 expression levels and saturation. |
| Secondary | Peripheral T-cell Levels and Activation in Response to Treatment | At cycle 1 days: 1, 2, 8, 15, & 22 prior to dosing | T-cell levels and activation will be measured in the peripheral blood after treatment. |
| Other | The 30 Day Mortality Rate | Up to 30 days | Number and percentage of patients that die within the first 30 days of initiating treatment. |
| Other | Overall Survival (OS) | Up to 1 year | OS is defined as the time from the initiation of study treatment until death from any cause, evaluated for up to 1 year. |
| Other | Progression Free Survival (PFS) | Up to 1 year | PFS is defined as the time from the initiation of study treatment until the time of disease progression or relapse. |
| Other | Duration of Remission (DOR) | Up to 1 year | Duration of remission is defined as the time from achieving complete response until the time of disease relapse. |
| Other | Compare the OS Between Patients Who Receive a Hematopoietic Stem Cell Transplant and Those Who Receive no Further Therapy Following Remission | Up to 1 year | |
| Other | Presence of Resistance Mutations in Bone Marrow at the Time of Disease Progression | Up to 28-days after the last dose |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02819804/registered