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N-803 for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Claudio Brunstein, MD, PhD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug to see if it helps people with leukemia or myelodysplastic syndrome after a transplant.

Eligible Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 Relapse

Secondary outcome measures

Chronic GVHD

Incidence of Acute Graft-versus-host Disease

Incidence of Adverse Events

+4 more

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT02989844

100%

Platelet count decreased

100%

White blood cell decreased

100%

Neutrophil count decreased

100%

Injection site reaction

100%

Anemia

100%

Hypertension

85%

Chills

75%

Hyperglycemia

75%

Dyspnea

60%

Fatigue

50%

Aspartate aminotransferase increased

50%

Rash maculo-papular

45%

Headache

40%

Edema limbs

40%

Skin and subcutaneous tissue disorders - Other, specify

40%

Fever

40%

Creatinine increased

35%

Nausea

35%

Upper respiratory infection

30%

Hypocalcemia

30%

Hypotension

25%

Lymphocyte count decreased

25%

Alanine aminotransferase increased

25%

Diarrhea

25%

Hyponatremia

20%

Hypermagnesemia

20%

Cough

20%

Vomiting

20%

Acute kidney injury

20%

Fall

20%

Hypoalbuminemia

20%

Gait disturbance

15%

Dizziness

15%

Infections and infestations - Other, specify

15%

Paronychia

10%

Abdominal pain

10%

Insomnia

10%

Dry eye

10%

Weight loss

10%

Atrial Fibrillation

10%

Hypomagnesemia

10%

Dry mouth

10%

General disorders and administration site conditions - Other, specify

10%

Alkaline phosphatase increased

Myalgia

Pain

Pleural effusion

Vasovagal reaction

Productive cough

Pneumonitis

Flu like symptoms

Anorexia

Lung infection

Pericardial effusion

Skin infection

Peripheral sensory neuropathy

Rash acneiform

Pain in extremity

Stomach pain

Allergic reaction

Neck pain

Sepsis

Dysphagia

Blood bilirubin increased

Blurred Vision

Back pain

Infections and infestations - Other,

Respiratory failure

Atrial fibrillation

Gastroesophageal reflux disease

Gastrointestinal disorders - Other, specify

Vulval infection

Musculoskeletal and connective tissue disorder - Other, specify

Bronchial obstruction

Wheezing

Erectile dysfunction

Breast pain

Generalized muscle weakness

Immune system disorders - Other,

Ear pain

Nasal congestion

Dry skin

Mucositis oral

100%

80%

60%

40%

20%

Study treatment Arm

N-803

Trial Design

1Treatment groups

Experimental Treatment

Group I: N-803Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N-803

2021

Completed Phase 2

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

271 Previous Clinical Trials

14,605 Total Patients Enrolled

Claudio Brunstein, MD, PhDPrincipal InvestigatorUniversity of Minnesota

7 Previous Clinical Trials

410 Total Patients Enrolled

Frequently Asked Questions

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

Are there any openings available in this trial currently?

"This research is no longer seeking enrolment; the trial was posted on April 12th 2017 and last updated February 25th 2022. Currently, 1651 studies are searching for patients with myelodysplastic syndromes while 20 trials are actively looking for individuals to participate in N-803 related medical experiments."

Answered by AI

Could you expound upon extant research conducted involving N-803?

"Currently, there are 20 studies happening that revolve around N-803 with 3 of these in the advanced Phase 3. Most sites researching this medication is located near Ann Arbor, however a total of 508 medical centres are conducting trials for N-803."

Answered by AI

Has N-803 been granted authorization from the FDA?

"It has been determined that N-803's safety is relatively established, thus receiving a score of 2. This conclusion was drawn as this particular trial is in the second phase which means there are data points confirming its security, but none to validate efficacy."

Answered by AI

How many participants are currently taking part in the experiment?

"This medical study is no longer recruiting new participants. The trial was initially put up on April 12th 2017 and the last update occured on February 25th 2022. For those looking for similar trials, there are 1,651 studies with open recruitment concerning myelodysplastic syndromes and 20 involving N-803 actively searching for patients."

Answered by AI

Does this research represent an original contribution to our field of study?

"N-803 has been under investigation since 2014. The initial research was sponsored by ImmunityBio, Inc., and involved 596 participants. Subsequently, N-803 earned Phase 1 & 2 drug approval after the first study in 2014. At present, there are 20 active studies for this medication located across 332 cities and one country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT

2017. "Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02989844.