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Bi-specific T-cell Engager (BiTE)

BLINCYTO for Leukemia

Q: How many individuals are being treated as part of this research?

That is accurate. The clinical trial in question, which was originally posted on June 11th 2021, is looking for 30 more patients from 1 site according to the most recent update on April 18th 2022.

Q: Has the FDA given its okay to use BLINCYTO (Blinatumomab)?

BLINCYTO (Blinatumomab) has received a Phase 2 designation, meaning that while there is some evidence to support its safety, more data is needed to confirm efficacy.

Q: Are individuals who meet the qualifications still able to join this research project?

The study, which is still recruiting patients, was first posted on clinicaltrials.gov on 6/11/2021 and was last edited on 4/18/22.

Q: What else is known about BLINCYTO (Blinatumomab)?

At this time, there are 46 ongoing studies for BLINCYTO (Blinatumomab), with 9 of them being Phase 3 trials. Most of the clinical trials related to BLINCYTO are located in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>; however, 2395 locations across the globe are running these sorts of tests.

Phase 2

Waitlist Available

Led By Ashkan Emadi, MD, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Age 18 years and older

ECOG performance status < 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing a drug to see if it's effective in treating patients with a certain type of leukemia that has come back or hasn't responded to treatment, or where there are still a small number of cancer cells remaining after treatment.

Who is the study for?

Adults with relapsed or refractory CD19-positive mixed phenotypic acute leukemia (MPAL) or those in remission but with detectable cancer cells after treatment. Participants must be over 18, have stable vital organ functions, and women of childbearing age must test negative for pregnancy. Those who've had a stem cell transplant should be past certain recovery milestones.Check my eligibility

What is being tested?

The trial is testing the effectiveness of blinatumomab for patients with specific types of acute leukemia that are either not responding to standard treatments or have lingering cancer cells post-treatment. The study focuses on how well this drug can treat these conditions.See study design

What are the potential side effects?

Blinatumomab may cause side effects such as allergic reactions, fever, headache, nausea, fatigue, and infections among others. Side effects vary from person to person based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can take care of myself but may not be able to do heavy physical work.

Select...

I had a stem cell transplant over 4 weeks ago, no major graft-vs-host disease, and stopped immunosuppressants for over a week.

Select...

My mixed phenotype acute leukemia (MPAL) had responded to initial treatment but has now returned.

Select...

I finished chemotherapy (except hydroxyurea) 2 weeks before starting the study and may have blood cell count issues due to my blood cancer.

Select...

My leukemia did not respond to the first treatment cycle.

Select...

My cancer is CD19-positive and either relapsed or didn't respond to treatment, or is in remission but still shows minimal signs of disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohort A response rate

Cohort B response rate

Secondary outcome measures

Cohort A survival

Cohort B survival

Other outcome measures

CD 19 measurement

CD3-positive measurement

Leukemic blasts evaluation

+1 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%

Pruritus

11%

Erythema

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Tremor

Epistaxis

Constipation

Neutrophil count decreased

Agitation

White blood cell count decreased

Immunodeficiency

Hypervolaemia

Alanine aminotransferase increased

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Rash maculo-papular

Decreased appetite

Fatigue

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

2Treatment groups

Experimental Treatment

Group I: Subjects with R/R CD19-positive MPALExperimental Treatment1 Intervention

Cohort A: Evaluate the efficacy of blinatumomab to achieve the best morphologic response after the first two cycles of therapy in subjects with morphologic R/R CD19-positive MPAL The treatment of blinatumomab consists of induction, consolidation and maintenance therapy Subject will receive study drug blinatumomab by continuous IV infusion (CIV) Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 14±3 days treatment-free interval for induction, 28±3 days treatment-free interval for consolidation, and 56±3 days treatment-free interval for maintenance The initial dose of blinatumomab is 9 mcg/day for 7 days. The target dose for rest of treatment is 28 mcg/day

Group II: Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRDExperimental Treatment1 Intervention

Cohort B: Evaluate the efficacy of blinatumomab to achieve MRD-negativity in subjects with CD19-positive MPAL in CR, or CRh, or CRi or CRp after receiving at least one chemotherapy block of standard ALL or AML treatment with MRD-positivity at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01% The treatment of blinatumomab consists of induction, consolidation and maintenance therapy Subject will receive study drug blinatumomab by continuous IV infusion (CIV) Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 14±3 days treatment-free interval for induction, 28±3 days treatment-free interval for consolidation, and 56±3 days treatment-free interval for maintenance. The dose of blinatumomab is 28 mcg/day

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

687 Previous Clinical Trials

374,644 Total Patients Enrolled

Ashkan Emadi, MD, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore

1 Previous Clinical Trials

5 Total Patients Enrolled

Vu Duong, MDPrincipal InvestigatorUniversity of Maryland, Baltimore

2 Previous Clinical Trials

33 Total Patients Enrolled

Media Library

Blinatumomab (Bi-specific T-cell Engager (BiTE)) Clinical Trial Eligibility Overview. Trial Name: NCT04827745 — Phase 2

Acute Leukemia Research Study Groups: Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRD, Subjects with R/R CD19-positive MPAL

Acute Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT04827745 — Phase 2

Blinatumomab (Bi-specific T-cell Engager (BiTE)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827745 — Phase 2

Frequently Asked Questions

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

How many individuals are being treated as part of this research?

"That is accurate. The clinical trial in question, which was originally posted on June 11th 2021, is looking for 30 more patients from 1 site according to the most recent update on April 18th 2022."

Answered by AI

Has the FDA given its okay to use BLINCYTO (Blinatumomab)?

"BLINCYTO (Blinatumomab) has received a Phase 2 designation, meaning that while there is some evidence to support its safety, more data is needed to confirm efficacy."

Answered by AI

Are individuals who meet the qualifications still able to join this research project?

"The study, which is still recruiting patients, was first posted on clinicaltrials.gov on 6/11/2021 and was last edited on 4/18/22."

Answered by AI

What else is known about BLINCYTO (Blinatumomab)?

"At this time, there are 46 ongoing studies for BLINCYTO (Blinatumomab), with 9 of them being Phase 3 trials. Most of the clinical trials related to BLINCYTO are located in Baltimore, Maryland; however, 2395 locations across the globe are running these sorts of tests."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL

2021. "Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827745.