← Back to Search

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)

Must not have

Active central nervous system (CNS) leukemia not resolved with IT chemotherapy during screening

Known infection with human immunodeficiency virus (HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My leukemia in the brain is not responding to spinal fluid chemotherapy.

Select...

I am HIV positive.

Select...

I have or had an autoimmune disease that could affect my brain or nerves.

Select...

I have a brain condition that needs treatment, like uncontrolled seizures.

Select...

I have an active or chronic infection with hepatitis B or C.

Select...

I have hepatitis but my viral load is undetectable.

Select...

I have signs or symptoms of an ongoing infection that is not under control.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

+16 more

Awards & Highlights

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.

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