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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 below
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I am 55 years old or older.
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I have been recently diagnosed with a specific type of leukemia that is not Philadelphia chromosome-positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

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 more

Trial 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
~1230

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,396 Total Patients Enrolled
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,443 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04994717 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy, Phase 3: Blinatumomab alternating with low-intensity chemotherapy, Phase 3: Standard of care (SOC) chemotherapy
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT04994717 — Phase 3
Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994717 — Phase 3
~146 spots leftby Dec 2026
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