Trial · NCT02819804
Nivolumab and Dasatinib in Treating Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT02819804, Phase 1, Terminated, Northwestern University; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab and Dasatinib in Treating Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Trials, record NCT02819804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02819804
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and Dasatinib in Treating Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT02819804
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Adult Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia
- Interventions
- Dasatinib, Laboratory Biomarker Analysis, Nivolumab, Pharmacological Study
- First posted
- 2016-06-30
- Last updated
- 2020-02-11
- Results first posted
- 2020-01-31
- Limitations and caveats
- The study was closed to accrual with only one patient enrolled. It did not meet its accrual goal of 22 patients due to slow accrual and funding issues.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Dose-Limiting Toxicity (DLT) | Up to 28 days | Only one patient was treated on study and this patient did not complete the DLT period and was not evaluable for this outcome measure or any of the outcome measures. Sample size too small for analysis. | ||
| SECONDARY | Incidence of Adverse Events | Up to 28-days after the last dose | |||
| SECONDARY | Rate of Complete Hematologic Remission (CR) | At 84 days (3 cycles) | |||
| SECONDARY | Rate of Molecular Remission | At 84 days (3 cycles) | |||
| 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 | |||
| SECONDARY | Serum Level of Nivolumab | 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 | |||
| SECONDARY | PD1 Expression Levels and Saturation in Bone Marrow | Baseline to 28-days after the last dose | |||
| SECONDARY | Peripheral T-cell Levels and Activation in Response to Treatment | At cycle 1 days: 1, 2, 8, 15, & 22 prior to dosing | |||
| OTHER_PRE_SPECIFIED | The 30 Day Mortality Rate | Up to 30 days |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Complete Cycle 1 (28 Days) | STARTED | Treatment (Dasatinib, Nivolumab) | 1 | |
| Complete Cycle 1 (28 Days) | COMPLETED | Treatment (Dasatinib, Nivolumab) | 0 | |
| Complete Cycle 1 (28 Days) | NOT COMPLETED | Treatment (Dasatinib, Nivolumab) | 1 | |
| Start Cycle 2 and Beyond | STARTED | Treatment (Dasatinib, Nivolumab) | 0 | |
| Start Cycle 2 and Beyond | COMPLETED | Treatment (Dasatinib, Nivolumab) | 0 | |
| Start Cycle 2 and Beyond | NOT COMPLETED | Treatment (Dasatinib, Nivolumab) | 0 | |
| Follow-up for 1 Year | STARTED | Treatment (Dasatinib, Nivolumab) | 1 | |
| Follow-up for 1 Year | COMPLETED | Treatment (Dasatinib, Nivolumab) | 1 | |
| Follow-up for 1 Year | NOT COMPLETED | Treatment (Dasatinib, Nivolumab) | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperglycemia | Metabolism and nutrition disorders | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | White blood cell decreased | Investigations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Neutrophil count decreased | Investigations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Papulopustular rash | Infections and infestations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Hypertension | Vascular disorders | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Hypotension | Vascular disorders | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Lipase increased | Investigations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Sepsis | Infections and infestations | Treatment (Dasatinib, Nivolumab) | 1 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Dasatinib, Nivolumab) | 1 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Dasatinib, Nivolumab) | 0 | 1 |
| Total, other adverse events | Treatment (Dasatinib, Nivolumab) | 1 | 1 |
| Total, serious adverse events | Treatment (Dasatinib, Nivolumab) | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02819804
GET https://conductscience.org/api/trials/v1/NCT02819804/events?page=2