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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);
Must not have
Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol.
Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 7-days prior to the start of blinatumomab to rule out pregnancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on any cancer treatments not listed in the study.
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I am not pregnant or breastfeeding and have taken a pregnancy test within the last 7 days.
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I do not have an ongoing infection that isn't getting better with treatment.
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I have a history of significant brain disease or currently have active brain disease.

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%
Erythema
11%
Pruritus
11%
Hypokalaemia
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Epistaxis
9%
Tremor
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%
Paronychia
6%
Decreased appetite
6%
Fatigue
6%
Rash maculo-papular
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%
Catheter placement
2%
Klebsiella infection
2%
Nervous system disorder
2%
Accidental overdose
2%
Perineal cellulitis
2%
Herpes virus infection
2%
Haematoma
2%
Engraftment syndrome
2%
Complication associated with device
2%
Oral pain
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
~1230

Find a Location

Who is running the clinical trial?

Michael BurkeLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
AmgenIndustry Sponsor
1,392 Previous Clinical Trials
1,381,085 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
~8 spots leftby Jul 2025
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