← Back to Search

Monoclonal Antibodies

Blinatumomab + Nivolumab (+/- Ipilimumab) for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Led By Ivana Gojo
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Philadelphia chromosome (Ph) positive (+) pre-B cell ALL OR Ph+ MPAL with specific criteria
Patients who were treated with blinatumomab or chimeric antigen receptor (CAR)-modified T cells targeting CD19 in the past with specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dosage of blinatumomab when given with nivolumab and ipilimumab to patients with a certain type of leukemia that has returned after initial treatment or did not respond to treatment.

Who is the study for?
This trial is for patients aged 16 or older with poor-risk CD19+ precursor B-lymphoblastic leukemia that's relapsed or refractory. It includes those over 60 who can't have standard treatment, and excludes pregnant women, breastfeeding mothers, and individuals with certain health conditions like uncontrolled illnesses or active CNS leukemia.Check my eligibility
What is being tested?
The study tests the safety and optimal doses of blinatumomab combined with nivolumab alone or alongside ipilimumab in treating specific leukemia. These are immunotherapies designed to help the immune system fight cancer by targeting tumor cells' growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, allergic responses similar to other monoclonal antibodies used in treatment, and possibly increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia is Philadelphia chromosome positive.
Select...
I was treated with blinatumomab or CAR T-cell therapy targeting CD19.
Select...
I am mostly active and can care for myself.
Select...
My leukemia is confirmed to be CD19+ pre-B cell ALL or CD19+ MPAL.
Select...
I am 16 years old or older.
Select...
I have had a stem cell transplant from a donor.
Select...
I am suspected to have a relapse or am newly diagnosed with a specific leukemia type and am 60 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Secondary outcome measures
Anti-leukemia activity
Complete remission
Complete remission with incomplete blood count recovery
+4 more
Other outcome measures
Changes in T cell co-signaling receptors expression
Changes in absolute lymphocyte count
Changes in cytokines levels in serum
+3 more

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
80%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Abdominal pain
13%
Rash
13%
Platelet count decreased
13%
Hypertension
11%
Pruritus
11%
Hypokalaemia
11%
Erythema
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Tremor
9%
Epistaxis
9%
Constipation
9%
Neutrophil count decreased
7%
Agitation
7%
White blood cell count decreased
7%
Immunodeficiency
7%
Hypervolaemia
7%
Alanine aminotransferase increased
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Decreased appetite
6%
Rash maculo-papular
6%
Fatigue
6%
Paronychia
6%
Back pain
6%
Nasopharyngitis
6%
Febrile neutropenia
6%
Urticaria
4%
Fluid balance positive
4%
Seizure
4%
Oropharyngeal pain
4%
Aplasia
4%
Pain in extremity
4%
Neurological symptom
4%
Aspartate aminotransferase increased
2%
Engraftment syndrome
2%
Nervous system disorder
2%
Klebsiella infection
2%
Catheter placement
2%
Herpes virus infection
2%
Haematoma
2%
Complication associated with device
2%
Perineal cellulitis
2%
Accidental overdose
2%
Oral pain
2%
Neurological examination abnormal
2%
Blood immunoglobulin G decreased
2%
Antithrombin III decreased
2%
Laryngotracheitis obstructive
2%
Pain
2%
Hypertransaminasaemia
2%
Rhinitis
2%
Body temperature increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab
HC3 Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (blinatumomab, nivolumab, ipilimumab)Experimental Treatment5 Interventions
Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 42 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes on day 11 and then every 2 weeks for up to year. Some patients also receive ipilimumab IV over 90 minutes on day 11 and then every 6 weeks for up to 1 year. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Blinatumomab
2014
Completed Phase 3
~1230
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,290 Total Patients Enrolled
Ivana GojoPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
4 Previous Clinical Trials
173 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02879695 — Phase 1
Acute Leukemia Research Study Groups: Treatment (blinatumomab, nivolumab, ipilimumab)
Acute Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02879695 — Phase 1
Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02879695 — Phase 1
~3 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top