Blinatumomab for Acute Lymphoblastic Leukemia

Overseen By Elias Jabbour, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, CNS leukemia, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests blinatumomab, a drug administered as injections under the skin, to determine its effectiveness in controlling minimal residual disease (MRD) and preventing the return of B-cell acute lymphoblastic leukemia (ALL). Participants will receive treatment in 35-day cycles, with injections in areas such as the arm or thigh. The trial seeks adults with B-cell ALL who are in remission but still have MRD. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that blinatumomab is likely to be safe for humans?

Research has shown that blinatumomab, administered as an injection under the skin, is generally safe. In one study, participants tolerated the treatment well. Common side effects were manageable and included reactions at the injection site and flu-like symptoms, such as fever and headache. Serious side effects occurred rarely. The FDA has already approved blinatumomab for other uses, indicating it has passed important safety checks for those conditions. This background provides some reassurance about its safety for this new trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute lymphoblastic leukemia, which often involve chemotherapy or stem cell transplants, blinatumomab is a unique experimental drug administered as injections under the skin. What sets blinatumomab apart is its mechanism of action as a bispecific T-cell engager (BiTE), which means it helps the immune system's T-cells directly target and destroy cancer cells. Researchers are excited because this targeted approach can potentially result in fewer side effects and improved effectiveness compared to traditional therapies. Additionally, the subcutaneous delivery method of blinatumomab offers a more convenient and potentially less invasive treatment option for patients.

What evidence suggests that blinatumomab might be an effective treatment for acute lymphoblastic leukemia?

Research shows that blinatumomab effectively treats B-cell acute lymphoblastic leukemia (B-ALL). In this trial, participants will receive blinatumomab as a subcutaneous injection. Studies have found that this method of administration in adults with relapsed leukemia led to promising results. Specifically, patients lived longer during a treatment phase aimed at strengthening remission. Early findings from other studies also suggest that this method maintains the drug's effectiveness and could be a viable option for patients. Overall, blinatumomab is considered a strong option for managing this type of leukemia. ^{3 4 5 6 7}

Who Is on the Research Team?

Elias Jabbour, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults (≥18 years) with B-cell Acute Lymphoblastic Leukemia who have measurable residual disease while in remission. Participants must understand the study, sign consent, have good organ function, and use contraception. Excluded are pregnant women, those allergic to Blinatumomab or its components, recently on other trials, with psychiatric issues affecting compliance, active infections/diseases including CNS involvement or history of such conditions.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

My kidney and liver functions are within the required limits.

I am 18 or older with B-cell ALL and have low levels of cancer cells despite being in remission.

Exclusion Criteria

Pregnant women

Known hypersensitivity to blinatumomab or to any component of the product formulation

No other investigational therapy within the past 14 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous blinatumomab in 35-day (5-week) treatment cycles

5 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Blinatumomab

Trial Overview The trial is testing if subcutaneous injections of Blinatumomab can control measurable residual disease and prevent relapse in patients with B-cell ALL. It's a Phase 2 study focusing on safety and effectiveness of this administration method for individuals who still show signs of leukemia after appearing to be in remission.

How Is the Trial Designed?

Group I: SQ blinatumomab Experimental Treatment 1 Intervention

Receiving blinatumomab as injections under the skin. The drug will be given in 35-day (5-week) treatment cycles. The injections may be given on various parts of the body, including the upper arm, thigh, stomach, and/or hips/buttocks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Amgen

Industry 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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40532723/

Subcutaneous blinatumomab in adults with relapsed or ... Treatment with subcutaneous blinatumomab at the two dose regimens of 250 μg/500 μg and 500 μg/1000 μg resulted in promising preliminary activity and a ...

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/1440/531864/Single-Agent-Subcutaneous-Blinatumomab-for

Single-Agent Subcutaneous Blinatumomab for Advanced B ... Results: At the data cut-off on May 9, 2024, 27 pts were treated with SC blinatumomab and had opportunity to be observed in long term follow up; ...

3. lymphoblastic-hub.com lymphoblastic-hub.com/medical-information/safety-and-efficacy-of-subcutaneous-blinatumomab-in-adult-patients-with-rr-b-all-phase-ib-trial

Safety and efficacy of subcutaneous blinatumomab in adult ... However, outcomes for adult patients with relapsed/refractory (R/R) B-ALL remain poor, and better treatments are warranted. Continuous ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07134088

A Study of Subcutaneous Blinatumomab in Children With R ... A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric ...

5. aob.amegroups.org aob.amegroups.org/article/view/11031/html

Immunotherapy with blinatumomab in B-cell acute ... Blinatumomab has shown significant efficacy in treating B-ALL. Consolidation treatment has resulted in major improvements in survival.

6. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/6122/488037/Safety-and-Pharmacokinetics-of-Subcutaneous

Safety and Pharmacokinetics of Subcutaneous Blinatumomab ... Conclusion: In this ongoing phase 1b dose-escalation study, SC blinatumomab demonstrated an acceptable safety profile and anti-leukemia ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf

BLINCYTO® (blinatumomab) for injection - accessdata.fda.gov The safety data described below reflect exposure to BLINCYTO in a randomized, open-label, active-controlled clinical study (TOWER Study) in which 376 patients ...