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Blinatumomab for Leukemia

Phase 2
Recruiting
Research Sponsored by Michael Burke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have acceptable organ function as defined within 7 days of study registration: Renal: creatinine clearance ≥ 60 mL/min/1.73m2 or serum creatinine based on age/gender; Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA
Patients with very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights

Study Summary

This trial is testing a new therapy to see if it can reduce leukemia before a patient gets a bone marrow transplant. The hope is that it will improve the patient's chances of survival.

Who is the study for?
This trial is for individuals up to 25 years old with B-cell Acute Lymphoblastic Leukemia (B-ALL) in remission but with minimal residual disease, planning to undergo a bone marrow transplant. They must have good organ function and performance status, no active infections or GVHD if post-transplant, and not be pregnant or breastfeeding. Participants need to agree to contraception use and can't have CNS leukemia or be on other cancer treatments.Check my eligibility
What is being tested?
The study tests blinatumomab as a 'bridging therapy' before hematopoietic cell transplantation (HCT). It aims to reduce leukemia cells further in patients who are already in remission but still have some remaining disease. The goal is improving outcomes after the transplant.See study design
What are the potential side effects?
Potential side effects of blinatumomab include allergic reactions, fever, headache, nausea, fatigue, insomnia, and infection risk increase. Some may experience neurological issues like seizures or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ALL is high-risk and I'm going for a stem cell transplant in my first remission.
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My heart's pumping ability is at least 40%.
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My liver tests are within the required range.
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I have a donor for a transplant and plan to undergo it after initial treatment.
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I have not had brain or spinal radiation during this therapy, and if I did, it was over 90 days ago.
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My kidney function is normal or near normal.
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I am 25 years old or younger.
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My B-ALL is in remission but still shows minimal signs of disease.
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My condition has worsened after initial improvement.
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My cancer remains after initial treatment, as shown by a specific blood test.
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I am mostly self-sufficient and can do most activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects FC-MRD Negative
Percentage of Subjects in CR
Secondary outcome measures
Percentage of Subjects that HTS-MRD Negative

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%
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%
Fatigue
6%
Rash maculo-papular
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%
Haematoma
2%
Herpes virus infection
2%
Complication associated with device
2%
Engraftment syndrome
2%
Perineal cellulitis
2%
Klebsiella infection
2%
Nervous system disorder
2%
Catheter placement
2%
Oral pain
2%
Accidental overdose
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: BlinatumomabExperimental Treatment1 Intervention
Up to 2 cycles of continuous infusion blinatumomab will be given based on the end of Cycle 1 disease response. Cycle 2 of blinatumomab can be given to subjects who have achieved remission (< 5% marrow blasts) after Cycle 1 but have persistent disease identified by multi-parameter flow cytometry (minimal residual disease (MRD) positive ≥ 0.01%) after Cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

Michael BurkeLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,071 Total Patients Enrolled
Michael Burke, MD1.01 ReviewsStudy Chair - Medical College of Wisconsin
Medical College of Wisconsin
4 Previous Clinical Trials
860 Total Patients Enrolled

Media Library

Blinatumomab Clinical Trial Eligibility Overview. Trial Name: NCT04556084 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Blinatumomab
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT04556084 — Phase 2
Blinatumomab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04556084 — Phase 2

Frequently Asked Questions

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

Could you provide a synopsis of the research that has been done with Blinatumomab?

"As of now, there are 46 clinical trials examining blinatumomab with 9 in phase 3. Although the bulk of these studies take place in Milwaukee, WI, there are 2395 sites conducting this research worldwide."

Answered by AI

Has Blinatumomab fulfilled the requirements to obtain FDA approval?

"The safety of Blinatumomab has been evaluated and given a score of 2, as this is only at the Phase 2 stage; no efficacy data yet exists."

Answered by AI

Is this trial enrolling participants at the present time?

"The clinical trial is open for enrollment, as indicated by information on the clinicaltrials.gov website. This medical study was initially posted in January 2021 and most recently updated at April 2022."

Answered by AI

What is the participant size of this clinical research?

"Affirmative. Clinicaltrials.gov's records demonstrate that this research project is actively seeking participants; it was initially posted on January 1st 2021, and the latest information update occurred April 4th 2022. 35 patients must be recruited from a single site for successful completion of the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blinatumomab Bridging Therapy
Michael Burke 2021. "Blinatumomab Bridging Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04556084.
~8 spots leftby Apr 2025
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