Inotuzumab + Blinatumomab for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two treatments, inotuzumab and blinatumomab (a type of immunotherapy), is safe and effective for treating B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. The focus is on individuals newly diagnosed with this specific leukemia. The trial seeks participants who might have other health issues, such as heart or lung problems, that make traditional chemotherapy unsuitable. Participants should have B-ALL positive for CD19 and CD22 markers, proteins found on certain cancer cells. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that patients who need ongoing systemic T-cell suppressive therapy are not eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that combining inotuzumab and blinatumomab is likely to be safe for humans?
Research has shown that blinatumomab, one of the treatments in this trial, has been studied for safety in patients with B-cell acute lymphoblastic leukemia (B-ALL). In these studies, some patients experienced side effects like cytokine release syndrome, where the immune system releases too many proteins into the blood, and neurological events. However, proper medical care generally managed these side effects.
While limited information exists on its use outside of studies, blinatumomab has improved survival rates in some groups. This suggests that despite potential side effects, the treatment might still be beneficial. Notably, the FDA has already approved blinatumomab for treating B-ALL, offering some reassurance about its safety in humans.
This trial aims to explore the safety of combining inotuzumab and blinatumomab for newly diagnosed patients. As a Phase 2 study, there is already some early evidence of safety, but this trial will provide more detailed information.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Blinatumomab for treating acute lymphoblastic leukemia (ALL) because, unlike traditional chemotherapy, it is a type of immunotherapy that uses bispecific T-cell engager (BiTE) technology. This means it can directly link T-cells to cancer cells, specifically targeting CD19+ and CD22+ proteins on B-cell leukemias. This innovative approach allows the immune system to attack cancer cells more precisely, potentially leading to fewer side effects and greater effectiveness compared to standard chemotherapy treatments.
What evidence suggests that combining inotuzumab and blinatumomab might be an effective treatment for B-cell acute lymphoblastic leukemia?
Research has shown that blinatumomab effectively treats B-cell acute lymphoblastic leukemia (B-ALL). One study found that all patients using blinatumomab showed no signs of cancer in their blood, achieving a 100% complete remission rate. Additionally, 87.2% of these patients had almost no detectable cancer after two treatment cycles, indicating that the cancer was nearly gone. These results are promising for blinatumomab in helping patients achieve remission and significantly reduce cancer in the body.3467
Who Is on the Research Team?
Jae Park, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) that's negative for the Philadelphia chromosome. Participants must have CD19+ and CD22+ expression, no severe cardiac issues, a certain level of kidney function, and be able to handle some physical activity (ECOG status of 2 or less).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive concurrent inotuzumab and subcutaneous blinatumomab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
Trial Overview
The study tests combining two drugs, inotuzumab and blinatumomab injections, to see if they're safe and effective against B-ALL. It's specifically for those who haven't been treated before.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be newly diagnosed with CD19+ and CD22+ B-cell Acute Lymphoblastic Leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer 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
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
1.
stjude.org
stjude.org/research/progress/2024/blinatumomab-added-to-chemo-improves-survival-for-adults-with-all.htmlBlinatumomab 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.
Blinatumomab consolidation in children with high-risk first ...
The KM analysis of survival at 60 months after alloHSCT revealed that 79.5% (95% CI, 65.2–88.5) of patients in the blinatumomab arm were alive ...
Real-world evidence on treatment pattern, effectiveness ...
The ND patients using blinatumomab induction therapy achieved 100% CR/CRi rate; 87.2% achieved MRD negativity within two cycles of blinatumomab. In R/R re- ...
4.
ashpublications.org
ashpublications.org/bloodadvances/article/9/15/3946/537699/Blinatumomab-use-in-pediatric-B-ALL-where-are-weBlinatumomab use in pediatric B-ALL: where are we now?
Among 70 patients who received the recommended dosage, 27 (39%) achieved a complete remission (CR; defined as no circulating blasts or ...
Real-world evidence on treatment pattern, effectiveness, and ...
Blinatumomab is efficacious in patients with B-cell acute lymphoblastic leukemia (B-ALL), yet limited real-world data exists in this context.
Safety and Efficacy of Blinatumomab- Real World Data
Despite improvement in survival of newly diagnosed adult ALL, the results of relapsed/refractory disease are still poor, with long term survival of < 10%.
Immunotherapy with blinatumomab in B-cell acute ...
Key efficacy outcomes included survival, duration of response, and degree of remission. Safety outcomes were cytokine release syndrome (CRS) and ...
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