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Bi-specific T-cell Engager (BiTE)
Blinatumomab for Acute Lymphoblastic Leukemia
Phase 4
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hemoglobin level greater than or equal to 90 g/L (transfusion permitted)
B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) with minimal/measurable residual disease defined as hematologic complete remission (CR) with less than 5% bone marrow blasts and meets clinical eligibility criteria to receive blinatumomab as outlined below.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is testing if a drug called blinatumomab is safe and effective for people with a certain type of leukemia.
Who is the study for?
Adults over 18 with B-precursor Acute Lymphoblastic Leukemia and minimal residual disease can join. They must have certain blood cell counts, normal liver/kidney function, be in good physical condition (ECOG PS of 0 or 1), not pregnant, able to wear health monitoring devices, and have a caregiver. Exclusions include CNS disorders, autoimmune diseases with CNS involvement, recent chemotherapy, other malignancies within the past two years (with exceptions), active infections or graft versus host disease.Check my eligibility
What is being tested?
The trial is testing the safety of outpatient Blinatumomab treatment for leukemia patients with minimal residual disease. It involves wearing a Current Wearable Health Monitoring System to track patient's health status during treatment.See study design
What are the potential side effects?
Blinatumomab may cause side effects like allergic reactions to its components, nerve problems that could affect coordination and speech (neurotoxicity), infusion-related reactions such as fever or chills, fatigue, headaches and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hemoglobin level is at least 90 g/L, transfusions are okay.
Select...
I have B-cell ALL in remission with less than 5% bone marrow blasts and can receive blinatumomab.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I have a caregiver at home 24/7 who can drive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cycle 1: Incidence of any adverse events requiring hospitalization
Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest
Cycle 2: Incidence of any adverse events requiring hospitalization
+1 moreSecondary outcome measures
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Incidence of Adverse events of Special interest
Incidence of treatment emergent Adverse events
+7 moreSide effects data
From 2022 Phase 3 trial • 111 Patients • NCT0239385980%
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
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 Treatment2 Interventions
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?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,061 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,534 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 90 g/L, transfusions are okay.I had a stem cell transplant from a donor within the last 12 weeks.You are allergic to any of the materials used in the medical device.My upper arm circumference is either below 20 cm or above 50 cm.I have a known hepatitis B or C infection.I have or had an autoimmune disease that could affect my brain or spinal cord.My breast ductal carcinoma in situ has been treated and shows no signs of disease.You don't have a good cell phone signal at home.I had skin cancer (not melanoma) treated and currently show no signs of it.I have had cancer other than my current one in the last 2 years.My kidney and liver are functioning well.I have B-cell ALL in remission with less than 5% bone marrow blasts and can receive blinatumomab.I am fully active or can carry out light work.I am currently being treated for GvHD with medication.I have no active cancer except for skin cancer or cervical pre-cancer.I have open wounds or injuries on both arms where a health device would be worn.My bladder cancer has been treated and is not invasive.My kidney function, measured by creatinine or GFR, is within normal limits.I have not had radiotherapy in the last 4 weeks.I am not pregnant, as confirmed by tests.I am not pregnant, breastfeeding, nor planning to during and for 48 hours after treatment.I am a woman able to have children and agree to use effective birth control during and 48 hours after treatment.My spinal fluid is currently clear of leukemia after treatment.My cancer was treated over 2 years ago, with no current signs of it and considered low risk for coming back.I do not have a history of serious brain or nerve conditions.You are allergic to blinatumomab or any of the ingredients in it.I am currently fighting an infection that needs treatment.I am at risk of severe heart rhythm problems due to a heart condition.I haven't had chemotherapy in the last 2 weeks.I have a prostate condition but no prostate cancer.You have a heart device called an implantable defibrillator.I am 18 years old or older.My cervical cancer was treated and shows no signs of being present.I have a caregiver at home 24/7 who can drive.My cancer has spread outside the bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Blinatumomab
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants in this research older than 25 years old?
"The lower age limit for this particular clinical trial is 18 years old, while the maximum age is 99."
Answered by AI
Are clinical trials for this medication prominent in Canada?
"To be clear, there are 9 sites running this trial currently. They are in Park Ridge, Omaha, Orange, and 6 other cities. It would be beneficial to choose the location that is closest to you to reduce travel time if you end up participating."
Answered by AI
Who does this trial target as participants?
"This study is seeking 45 individuals with leukemia, lymphocytic, acute, L1 aged 18 and 99. Most importantly, candidates must meet the following criteria:-Subject has provided informed consent prior to initiation of any study-specific activities/procedures OR subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent-Less than 5% bone marrow blasts-Platelets greater than or equal to"
Answered by AI
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