Blinatumomab + Chemotherapy 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: Anti-leukemia therapy

Disqualifiers: Pregnancy, HIV, Hepatitis, CNS disease, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of blinatumomab (a type of immunotherapy) combined with low-intensity chemotherapy for individuals with B-ALL, a type of blood cancer. The goal is to evaluate the effectiveness of this combination, particularly for older patients or those unable to undergo intensive chemotherapy. Suitable candidates include individuals diagnosed with B-ALL who have not received intensive treatment before, especially if they have heart or lung issues affecting daily life. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from potentially effective therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, no other anti-leukemia therapy is allowed during the trial, except for specific cases involving tyrosine kinase inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found blinatumomab to be generally safe. Patients experienced varying results, but most tolerated it well. Another study showed that when combined with other treatments, 44% of patients responded positively, indicating it is manageable for many.

Mini-CVD chemotherapy appears safe for those who might not tolerate stronger treatments. It has been used safely in older adults, although some studies noted more side effects in people over 60.

The MTX/ARA-C chemotherapy demonstrated a high success rate, with 90.4% of patients achieving complete remission after the first cycle and a low death rate of 1.9% during treatment. This suggests it is relatively safe for many patients.

Overall, research has found these treatments to be generally safe, but like any treatment, side effects may occur. Always consult a healthcare provider to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Blinatumomab is unique because it leverages a novel mechanism of action as a bispecific T-cell engager (BiTE), which directs the body’s immune system to target and destroy leukemia cells. Unlike traditional chemotherapy, which broadly attacks rapidly dividing cells, Blinatumomab specifically binds to CD19 on B-cells and CD3 on T-cells, facilitating a more targeted immune response. Researchers are excited about this treatment because it offers the potential for increased specificity and reduced systemic toxicity compared to standard chemotherapy options for acute lymphoblastic leukemia.

What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?

Research shows that blinatumomab effectively treats B-cell acute lymphoblastic leukemia (B-ALL). Studies have found that blinatumomab helps adults with B-ALL live longer than chemotherapy alone, particularly if the cancer has returned or hasn't responded to treatment. Specifically, in patients with minimal residual disease (MRD+), 78% achieved a complete response after taking blinatumomab. In this trial, participants will receive blinatumomab combined with a gentler form of chemotherapy, such as mini-CVD, with or without MTX/ARA-C, depending on their age and health status. This combination aims to improve outcomes while reducing treatment intensity. ^{2 6 7 8 9}

Who Is on the Research Team?

Elias Jabbour, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for older or unfit patients with newly diagnosed B-cell Acute Lymphoblastic Leukemia (B-ALL). Participants should meet specific health criteria to be eligible. The full list of inclusion and exclusion criteria is not provided here.

Inclusion Criteria

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

I am 60 or older with B-ALL and may have had up to 2 treatments.

I am 18-59 years old with B-ALL and can't undergo intensive chemotherapy but may have had up to 2 cycles of therapy.

Exclusion Criteria

Pregnant women

Known HIV-positive patients

Unable/unwilling to sign informed consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction-Consolidation Treatment

Participants receive a total of 8 cycles of induction-consolidation treatment with Mini-CVD + MTX/ARA-C + Blinatumomab or Mini-CVD + Blinatumomab depending on age and fitness

8 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Blinatumomab
• Mini-CVD
• MTX/ARA-C

Trial Overview The study tests the safety and effectiveness of Blinatumomab, a targeted cancer drug, given under the skin along with low-intensity chemotherapy (Mini-CVD, MTX/ARA-C) in a single group of participants without comparing it to another treatment.

How Is the Trial Designed?

Group I: Age>70 years: Mini-CVD + Blinatumomab Experimental Treatment 2 Interventions

Participants older than 70 years of age will receive 1 cycle of mini-CVD in combination with SC Blinatumomab followed by SC Blinatumomab alone for 7 cycles for a total of 8 cycles of treatment.

Group II: Age 18-59 years or 60-70 years: Mini-CVD + MTX/ARA-C + Blinatumomab Experimental Treatment 3 Interventions

Participants who are 60-70 years of age or 18-59 years of age and unfit for intensive chemotherapy will receive a total of 8 cycles of induction-consolidation cycles.

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/39479863/

Outcomes of children and young adults with B-cell acute ... Our results indicate that HSCT following blinatumomab in children and YA with B-ALL is highly effective, being associated with low NRM and not affecting the ...

2. ashpublications.org ashpublications.org/bloodadvances/article/9/15/3946/537699/Blinatumomab-use-in-pediatric-B-ALL-where-are-we

Blinatumomab use in pediatric B-ALL: where are we now? With a median follow-up of 43 months, blinatumomab significantly improved OS and relapse-free survival (RFS) compared with chemotherapy alone (3 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1609783

Blinatumomab versus Chemotherapy for Advanced Acute ... Treatment with blinatumomab resulted in significantly longer overall survival than chemotherapy among adult patients with relapsed or refractory B-cell ...

4. stjude.org stjude.org/research/progress/2024/blinatumomab-added-to-chemo-improves-survival-for-adults-with-all.html

Blinatumomab added to chemotherapy improves survival ... B-cell precursor acute lymphoblastic leukemia (B-ALL) has a cure rate exceeding 85% in children, but outcomes in adults are poor.

5. nature.com nature.com/articles/s41408-022-00766-7

Real-world use of blinatumomab in adult patients with B ... In a Phase 2 trial in patients with MRD+ B-cell ALL, 78% of patients receiving blinatumomab achieved a complete MRD response, which was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12325004/

Blinatumomab in pediatric B-acute lymphoblastic leukemia Extended follow-up data revealed that patients receiving blinatumomab consolidation therapy maintained event-free survival (EFS) exceeding 50% ...

7. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2411680

Blinatumomab in Standard-Risk B-Cell Acute ... The estimated 3-year disease-free survival among patients with an average relapse risk was 97.5±1.3% with blinatumomab and chemotherapy and 90.2 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0145212625005880

Efficacy and safety of blinatumomab for CD19 + acute ... One-year OS rates of 66.7 %, 91.7 %, and 22.2 % observed in the frontline, consolidation, and relapsed/refractory settings were similar to rates seen in ...

9. nature.com nature.com/articles/s41408-024-01179-4

Frontline Ph-negative B-cell precursor acute lymphoblastic ... Additionally, 3-year relapse-free survival was 80% for the blinatumomab arm versus 64% for chemotherapy alone (HR, 0.53 [95% CI, 0.32–0.87]; P = ...