Blinatumomab + HMCT for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and evaluate the effectiveness of combining two treatments for Acute Lymphoblastic Leukemia (ALL), a challenging type of blood cancer. It combines the standard drug blinatumomab (Blincyto) with a specialized cell therapy from a family member. The trial seeks participants whose cancer has returned or is unresponsive to other treatments, particularly those with a family member willing to donate cells. Participants should have ALL that impacts their daily lives and have not succeeded with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as mycophenolate, cyclosporine, and prednisone over 20mg/day, as well as other immunosuppressive agents. However, low dose maintenance chemotherapy and low dose prednisone are allowed until 24 hours before starting blinatumomab. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that blinatumomab is generally safe for patients with certain types of leukemia. It is already approved for treating this condition, indicating a reliable safety record. However, combining blinatumomab with Haplo-Mismatched Cellular Therapy (HMCT) is a newer approach.
In a safety study, researchers administered donor T cells (a type of white blood cell) along with blinatumomab. The study tested different doses to determine the safest amount. There is a risk of unwanted reactions, such as graft-versus-host disease, where donor cells attack the body. Researchers aimed to manage this risk by carefully adjusting doses.
Overall, this treatment combination remains in the early testing stages. This trial phase means researchers are still learning the best and safest way to use these treatments together. Ensuring participants' safety is a top priority, and the trial will closely monitor for side effects.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for Acute Lymphoblastic Leukemia, which often include chemotherapy and targeted therapies, Blinatumomab in combination with Haplo-Mismatched Cell Therapy (HMCT) introduces a unique approach. Blinatumomab is a bispecific T-cell engager (BiTE) antibody that specifically targets CD19 on leukemia cells and activates the body's T-cells to attack these cancerous cells. Researchers are excited about this treatment because it harnesses the immune system in a novel way, potentially offering more precise targeting of leukemia cells while sparing healthy cells, which could lead to fewer side effects and improved outcomes compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?
Research has shown that blinatumomab effectively treats acute lymphoblastic leukemia (ALL). Studies have found that it can help patients with B-cell ALL live longer without disease recurrence. Blinatumomab aids the immune system in identifying and destroying cancer cells. In this trial, participants will receive a combination of blinatumomab and haplo-mismatched cell therapy (HMCT). This combination uses special immune cells from a family donor to enhance the patient's immune response. Together, these treatments show potential for improved outcomes in fighting ALL.15678
Who Is on the Research Team?
Noah Merin, MD PhD
Principal Investigator
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Are You a Good Fit for This Trial?
Adults with relapsed/refractory CD19+ Acute Lymphoblastic Leukemia, including those who've had prior blinatumomab treatment without severe side effects. Participants need a haploidentical family member donor for cell therapy, good organ function, and no recent major surgery or active CNS disease. They must not be pregnant and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive blinatumomab and one infusion of HMCT starting on day 15 after initial CRS resolution
Treatment Cycle 2
Participants receive blinatumomab and two infusions of HMCT with dose escalation based on T cell content
Follow-up
Participants are monitored for safety, side effects, and effectiveness of the treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
- Haplo-Mismatched Cell Therapy (HMCT)
Blinatumomab is already approved in European Union, United States for the following indications:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- High-risk first relapse BCP-ALL
- 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?
Cedars-Sinai Medical Center
Lead Sponsor
Amgen
Industry Sponsor
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