284 Participants Needed

Blinatumomab and Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting at 188 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Blinatumomab for treating acute lymphoblastic leukemia?

Blinatumomab has been shown to improve survival and remission rates in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). In a study, patients receiving Blinatumomab had a higher complete remission rate (34%) compared to those receiving standard chemotherapy (16%), and a longer median survival time (7.7 months vs. 4.0 months).12345

Is Blinatumomab safe for humans?

Blinatumomab has been used in clinical trials for acute lymphoblastic leukemia and is generally considered safe, but it can cause side effects like cytokine release syndrome (a severe immune reaction) and neurological issues such as tremors and depression. It has a favorable safety profile compared to standard chemotherapy, with less risk of severe blood-related side effects.12367

How is the drug Blinatumomab different from other treatments for acute lymphoblastic leukemia?

Blinatumomab is unique because it is a bispecific T-cell engager that helps the body's immune system target and destroy leukemia cells, and it has a more favorable toxicity profile compared to standard chemotherapy, which often causes severe side effects.23589

Research Team

M

MD

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion 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.
I can care for myself but may not be able to do heavy physical work, unless it's due to my leukemia.
See 2 more

Exclusion Criteria

My leukemia in the brain is not responding to spinal fluid chemotherapy.
I am HIV positive.
I have B cell ALL and may have had initial chemo but not started the main treatment yet.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy

Up to 14 weeks
Multiple visits for monitoring and dose adjustments

Phase 3 Treatment

Participants receive blinatumomab alternating with low-intensity chemotherapy or standard of care chemotherapy

Up to 5 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

  • Blinatumomab
  • Low-intensity chemotherapy regimen
  • SOC chemotherapy regimen
Trial OverviewThe 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.
Participant Groups
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.

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Blincyto for:
  • Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
  • High-risk first relapse BCP-ALL
🇺🇸
Approved in United States as Blincyto for:
  • Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
  • First or second complete remission with minimal residual disease (MRD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

Blinatumomab has been approved for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL), showing a significant improvement in overall survival and complete remission rates compared to standard chemotherapy, with a median survival of 7.7 months versus 4.0 months for chemotherapy.
In clinical trials, blinatumomab demonstrated a complete remission rate of 34% in Philadelphia chromosome (Ph)-negative ALL and 31% in Ph-positive ALL, while also presenting some adverse events like cytokine release syndrome and neurological issues, although it had fewer cases of neutropenia and infections compared to standard treatments.
FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.Pulte, ED., Vallejo, J., Przepiorka, D., et al.[2019]
In a phase 3 clinical trial involving 669 patients aged 1 to 30 years with first relapse of B-cell acute lymphoblastic leukemia (B-ALL), substituting blinatumomab for intensive chemotherapy in consolidation therapy showed a 2-year disease-free survival rate of 54.4% compared to 39.0% for the chemotherapy group, suggesting a potential benefit of blinatumomab in this high-risk population.
Blinatumomab also demonstrated a better safety profile, with significantly lower rates of serious adverse events such as infections and febrile neutropenia compared to traditional chemotherapy, indicating it may be a safer option for treating relapsed B-ALL.
Effect of Postreinduction Therapy Consolidation With Blinatumomab vs Chemotherapy on Disease-Free Survival in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.Brown, PA., Ji, L., Xu, X., et al.[2021]
Blinatumomab (Blincyto) achieved a complete remission in 33% of patients with relapsed or refractory Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL), indicating its efficacy as a treatment option.
However, the treatment is associated with frequent grade 3 or 4 adverse effects, highlighting the need for careful monitoring of patients during therapy.
Blinatumomab (Blincyto) for acute lymphoblastic leukemia.[2015]

References

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia. [2019]
Effect of Postreinduction Therapy Consolidation With Blinatumomab vs Chemotherapy on Disease-Free Survival in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. [2021]
Blinatumomab (Blincyto) for acute lymphoblastic leukemia. [2015]
Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia. [2017]
A closer look at blinatumomab. [2018]
Blinatumomab as a bridge to further therapy in cases of overwhelming toxicity in pediatric B-cell precursor acute lymphoblastic leukemia: Report from the Israeli Study Group of Childhood Leukemia. [2020]
Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. [2021]
Population Pharmacokinetics of Blinatumomab in Pediatric and Adult Patients with Hematological Malignancies. [2021]
Changes in clinical laboratory parameters and pharmacodynamic markers in response to blinatumomab treatment of patients with relapsed/refractory ALL. [2022]