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Monoclonal Antibodies
Blinatumomab and Chemotherapy for Acute Lymphoblastic Leukemia
Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 55 years at the time of informed consent
Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial is testing whether blinatumomab is safe and whether it can help people with B-cell acute lymphoblastic leukemia live longer without the disease getting worse.
Who is the study for?
Adults aged 55+ with newly diagnosed Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL) can join. Those 40-54 with severe comorbidities may also qualify. Participants need an ECOG performance status ≤2, adequate kidney and liver function, and a heart ejection fraction ≥50%. Exclusions include active CNS leukemia, autoimmune diseases affecting the CNS, HIV/Hepatitis B or C infections, uncontrolled chronic infections, or prior cancer chemotherapy for ALL.Check my eligibility
What is being tested?
The trial is testing blinatumomab alternating with low-intensity chemotherapy against standard of care (SOC) chemotherapy in older adults. It aims to see which treatment is safer and improves event-free survival (EFS) and overall survival (OS). The first part checks safety; the second compares how long patients live without events like disease worsening.See study design
What are the potential side effects?
Blinatumomab might cause flu-like symptoms, headaches, fever, nausea and can affect blood pressure or heart rate. Low-intensity chemo could lead to fatigue, mild nausea or hair thinning. Standard chemo often has stronger side effects like more intense nausea/vomiting, hair loss and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
I have been recently diagnosed with a specific type of leukemia that is not Philadelphia chromosome-positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 3: Event-free Survival (EFS)
Phase 3: Overall Survival (OS)
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Nausea
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
+30 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapyExperimental Treatment2 Interventions
The safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.
The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.
Group II: Phase 3: Blinatumomab alternating with low-intensity chemotherapyExperimental Treatment2 Interventions
Participants will receive blinatumomab alternating with low-intensity chemotherapy.
Group III: Phase 3: Standard of care (SOC) chemotherapyActive Control1 Intervention
Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
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
1,370 Previous Clinical Trials
1,377,401 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,864 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been recently diagnosed with a specific type of leukemia that is not Philadelphia chromosome-positive.I am 55 years old or older.My leukemia in the brain is not responding to spinal fluid chemotherapy.I am HIV positive.I can care for myself but may not be able to do heavy physical work, unless it's due to my leukemia.I am 40-55 years old with serious health conditions like severe diabetes, liver disease, or a BMI ≥ 40.I have B cell ALL and may have had initial chemo but not started the main treatment yet.I have or had an autoimmune disease that could affect my brain or nerves.I have a brain condition that needs treatment, like uncontrolled seizures.I have an active or chronic infection with hepatitis B or C.I have hepatitis but my viral load is undetectable.I have signs or symptoms of an ongoing infection that is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy
- Group 2: Phase 3: Blinatumomab alternating with low-intensity chemotherapy
- Group 3: Phase 3: Standard of care (SOC) chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Can people over the age of 20 years participate in this clinical trial?
"This experiment is only testing people who are between the ages of 40 and 100."
Answered by AI
If so, could you please share the findings of prior research on Blinatumomab?
"The first clinical trials testing blinatumomab's efficacy were conducted in 2011 at M D Anderson Cancer Center. As of right now, there are 15 completed trials and 47 ongoing ones. Many of the active studies are based in Houston, Texas."
Answered by AI
Has Blinatumomab been cleared by the FDA?
"Blinatumomab has received a safety score of 3. This is based on the fact that it is in Phase 3 clinical trials, which suggests that not only does this medication show some efficacy, but also that there is data supporting its safety from multiple rounds of testing."
Answered by AI
To how many people will this clinical trial give treatment?
"In order to carry out this study, we require 287 patients who meet the specified inclusion criteria. These participants can come from various locations, such as University of Texas MD Anderson Cancer Center in Houston, Texas and AdventHealth Orlando in Orlando, Florida."
Answered by AI
Are applications still being taken for this research project?
"Yes, this information is available on the clinicaltrials.gov website. The trial was posted on November 2nd 2021 and updated for the last time on October 12th, 2022."
Answered by AI
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