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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

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My leukemia is Philadelphia chromosome positive.

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I was treated with blinatumomab or CAR T-cell therapy targeting CD19.

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I am mostly active and can care for myself.

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My leukemia is confirmed to be CD19+ pre-B cell ALL or CD19+ MPAL.

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I am 16 years old or older.

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I have had a stem cell transplant from a donor.

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I am suspected to have a relapse or am newly diagnosed with a specific leukemia type and am 60 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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%

Rash

13%

Abdominal pain

13%

Platelet count decreased

13%

Hypertension

11%

Erythema

11%

Hypokalaemia

11%

Pruritus

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Tremor

Epistaxis

Constipation

Neutrophil count decreased

White blood cell count decreased

Immunodeficiency

Agitation

Hypervolaemia

Alanine aminotransferase increased

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Decreased appetite

Fatigue

Rash maculo-papular

Paronychia

Back pain

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Haematoma

Herpes virus infection

Klebsiella infection

Accidental overdose

Nervous system disorder

Perineal cellulitis

Catheter placement

Engraftment syndrome

Complication associated with device

Oral pain

Neurological examination abnormal

Blood immunoglobulin G decreased

Antithrombin III decreased

Laryngotracheitis obstructive

Pain

Hypertransaminasaemia

Rhinitis

Body temperature increased

100%

80%

60%

40%

20%

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

~1730

Blinatumomab

2014

Completed Phase 3

~1210

Ipilimumab

2014

Completed Phase 3

~2670

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,129 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited to this particular experiment?

"To enroll in this research study, 30 participants of appropriate age and health needs to be registered. The trial is open for enrollment at Yale University located in New Haven, Connecticut or Johns Hopkins University/Sidney Kimmel Cancer Center based in Baltimore, Maryland."

Answered by AI

Are there additional researches involving Blinatumomab?

"In 2009, the initial research on blinatumomab was conducted at Texas Children's Hospital. Since then, 388 trials have been completed and 810 are currently recruiting participants. Numerous of these ongoing studies occur in New Haven, Connecticut."

Answered by AI

What is Blinatumomab's primary application in the medical field?

"Blinatumomab is a viable treatment for unresectable melanoma as well as squamous cell carcinoma, refractory b-cell precursor acute lymphoblastic leukemia, and cases with a high risk of recurrence."

Answered by AI

Are recruitment efforts ongoing for this clinical experiment?

"The clinical trial is presently recruiting patients, as indicated on the website of clinicaltrials.gov. The study was created 5/5/2017 and last updated 11/24/2022."

Answered by AI

Are there any recognized risks associated with the usage of Blinatumomab?

"There is minimal clinical data signifying the safety of blinatumomab, thus it has been given a score of 1."

Answered by AI

In what geographic areas is this clinical trial currently taking place?

"At the moment, this study is enrolling patients from 4 different sites. Examples include Yale University in New Haven and Johns Hopkins/Sidney Kimmel Cancer Centerin Baltimore. The list also features Dana-Farber Cancer Institute in Boston alongside other medical centres."

Answered by AI

Recent research and studies

HematologyJournal

Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia

Shi, Zheng, Yiqian Zhu, Jing Zhang, and Baoan Chen. 2022. “Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia”. Hematology. Informa UK Limited. doi:10.1080/16078454.2022.2074704.

HematologyJournal

Monoclonal Antibodies: New Chance in the Management of B-cell Acute Lymphoblastic Leukemia

clinicaltrials.govStudy

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

2017. "Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02879695.

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