Blinatumomab for Acute Leukemia

Yale University, New Haven, CT
Acute Leukemia+3 More ConditionsBlinatumomab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Mixed Phenotype Acute Leukemia
  • B-cell Acute Lymphoblastic Leukemia (ALL)
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory B Acute Lymphoblastic Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Blinatumomab

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Year 2
Changes in T cell co-signaling receptors expression
Changes in absolute lymphocyte count
Changes in cytokines levels in serum
B-Lymphocytes
Year 2
Overall survival
Year 2
Duration of response
Up to 2 years
Anti-leukemia activity
Changes in expression of co-signaling molecules on leukemia blasts
Characterization of T cell transcriptional signature
Complete remission
Complete remission with incomplete blood count recovery
Incidence of adverse events
Maximum tolerated dose
Minimal residual disease
Progressive disease

Trial Safety

Phase-Based Safety

1 of 3

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1
SNDX-5613
1
MRX-2843
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Blinatumomab

Side Effects for

Blinatumomab
80%Pyrexia
41%Nausea
35%Headache
30%Vomiting
22%Anaemia
20%Diarrhoea
17%Stomatitis
17%Mucosal inflammation
13%Hypertension
13%Rash
13%Abdominal pain
13%Platelet count decreased
11%Hypogammaglobulinaemia
11%Pruritus
11%Hypokalaemia
11%Erythema
11%Hypotension
9%Neutropenia
9%Tremor
9%Epistaxis
9%Constipation
9%Neutrophil count decreased
7%Agitation
7%Cough
7%Thrombocytopenia
7%Abdominal pain upper
7%Fluid overload
7%Immunodeficiency
7%White blood cell count decreased
7%Alanine aminotransferase increased
6%Fatigue
6%Nasopharyngitis
6%Paronychia
6%Back pain
6%Rash maculo-papular
6%Febrile neutropenia
6%Petechiae
6%Urticaria
6%Decreased appetite
4%Seizure
4%Oropharyngeal pain
4%Aplasia
4%Pain in extremity
4%Neurological symptom
4%Fluid balance positive
4%Aspartate aminotransferase increased
2%Oral pain
2%Herpes virus infection
2%Hypertransaminasaemia
2%Klebsiella infection
2%Perineal cellulitis
2%Catheter placement
2%Antithrombin III decreased
2%Haematoma
2%Accidental overdose
2%Rhinitis
2%Neurological examination abnormal
2%Body temperature increased
2%Nervous system disorder
2%Blood immunoglobulin G decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02393859) in the Blinatumomab ARM group. Side effects include: Pyrexia with 80%, Nausea with 41%, Headache with 35%, Vomiting with 30%, Anaemia with 22%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (blinatumomab, nivolumab, ipilimumab)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Blinatumomab · No Placebo Group · Phase 1

Treatment (blinatumomab, nivolumab, ipilimumab)Experimental Group · 5 Interventions: Bone Marrow Aspiration and Biopsy, Biospecimen Collection, Nivolumab, Blinatumomab, Ipilimumab · Intervention Types: Procedure, Procedure, Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~810
Nivolumab
FDA approved
Blinatumomab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,275 Previous Clinical Trials
41,234,782 Total Patients Enrolled
Ivana GojoPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
4 Previous Clinical Trials
173 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have pre-B cell ALL or mixed phenotype acute leukemia (MPAL) that has not responded to previous treatments, or you are newly diagnosed and aged 60 or older.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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