Trial · NCT02879695

Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia

NCT02879695, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia. Trials, record NCT02879695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02879695

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
NCT number: NCT02879695
Status: Active not recruiting
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory Mixed Phenotype Acute Leukemia
Interventions: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy, Ipilimumab, Nivolumab
First posted: 2016-08-26
Last updated: 2026-08-20
Results first posted: 2024-10-16

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Up to 5.5 years	All participants who started treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Dose Limiting Toxicities	Up to 5.5 years	Only participants who started Nivolumab, with or without Ipilimumab, were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Count of Participants Responders With Minimal Residual Disease	Up to 5.5 years	Only participants with a clinical response (i.e. achieving remission) were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Achieving Remission	Up to 5.5 years	All participants who started treatment were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response	Up to 5.5 years	Only responders were included in the analysis.	Days	MEDIAN
SECONDARY	Overall Survival	Up to 5.5 years	Only participants who started nivolumab, with or without ipilimumab, were analyzed.	Days	MEDIAN
OTHER_PRE_SPECIFIED	Changes in Absolute Lymphocyte Count	About 1 year
OTHER_PRE_SPECIFIED	Changes in Distribution of T Cell Subsets and Differentiation Status, Natural Killer (NK) Cells, and B Cells	About 1 year
OTHER_PRE_SPECIFIED	Changes in T Cell Co-signaling Receptors Expression	About 1 year
OTHER_PRE_SPECIFIED	Changes in Expression of Co-signaling Molecules on Leukemia Blasts	About 1 year

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level A1	Grade 5	0	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level B1	Grade 5	1	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level B-1	Grade 5	1	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Expansion (Dose Level A1)	Grade 5	0	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level A1	Grade 4	7	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level B1	Grade 4	2	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level B-1	Grade 4	7	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Expansion (Dose Level A1)	Grade 4	3	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level A1	Grade 3	1	Participants
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events	Dose Level B1	Grade 3	0	Participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dose Level A1	8
Overall Study	STARTED	Dose Level B1	3
Overall Study	STARTED	Dose Level B-1	11
Overall Study	STARTED	Dose Expansion (Dose Level A1)	6
Overall Study	COMPLETED	Dose Level A1	6
Overall Study	COMPLETED	Dose Level B1	3
Overall Study	COMPLETED	Dose Level B-1	8
Overall Study	COMPLETED	Dose Expansion (Dose Level A1)	6
Overall Study	NOT COMPLETED	Dose Level A1	2
Overall Study	NOT COMPLETED	Dose Level B1	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events904

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
other	Anemia	Blood and lymphatic system disorders	Dose Level A1	4	8
other	Anemia	Blood and lymphatic system disorders	Dose Level B1	2	3
other	Anemia	Blood and lymphatic system disorders	Dose Level B-1	5	11
other	Anemia	Blood and lymphatic system disorders	Dose Expansion (Dose Level A1)	2	6
other	Bicarbonate Decrease	Blood and lymphatic system disorders	Dose Level A1	0	8
other	Bicarbonate Decrease	Blood and lymphatic system disorders	Dose Level B1	0	3
other	Bicarbonate Decrease	Blood and lymphatic system disorders	Dose Level B-1	1	11
other	Bicarbonate Decrease	Blood and lymphatic system disorders	Dose Expansion (Dose Level A1)	0	6
other	Blood Bicarbonate Decreased	Blood and lymphatic system disorders	Dose Level A1	0	8
other	Blood Bicarbonate Decreased	Blood and lymphatic system disorders	Dose Level B1	0	3

1 to 10 of 904Source ClinicalTrials.gov

See all 904 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dose Level A1	5	8
Total, all-cause mortality	Dose Level B1	2	3
Total, all-cause mortality	Dose Level B-1	5	11
Total, all-cause mortality	Dose Expansion (Dose Level A1)	2	6
Total, other adverse events	Dose Level A1	8	8
Total, other adverse events	Dose Level B1	3	3
Total, other adverse events	Dose Level B-1	10	11
Total, other adverse events	Dose Expansion (Dose Level A1)	6	6
Total, serious adverse events	Dose Level A1	5	8
Total, serious adverse events	Dose Level B1	2	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35622074	DERIVED

Source PubMed

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
UM1CA186691	The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies	CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2014 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02879695

GET https://conductscience.org/api/trials/v1/NCT02879695/results?page=2

API reference For AI assistants