Immunotherapy for Infant Leukemia
Recruiting in Palo Alto (17 mi)
+25 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Tanja Andrea Gruber
No Placebo Group
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that only limited prior therapy is allowed. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Blinatumomab (Blincyto) for treating infant leukemia?
Research shows that Blinatumomab is effective in treating certain types of leukemia by helping the body get rid of cancer cells, especially in cases where other treatments have not worked well. In infants with leukemia, it has shown promise in achieving remission before further treatment, with some patients experiencing long-term survival.
12345Is blinatumomab (Blincyto) safe for use in humans?
Blinatumomab has been used in children and adults with certain types of leukemia, but it can cause serious side effects like cytokine release syndrome (a severe immune reaction) and neurological problems (such as seizures). Other common side effects include fever, headache, and nausea.
24678How is the drug blinatumomab different from other treatments for infant leukemia?
Blinatumomab is unique because it is a bispecific T-cell engager, which means it helps the body's immune cells target and destroy cancer cells. This drug is used for certain types of leukemia that have relapsed or are hard to treat, and it works differently from traditional chemotherapy by directly engaging the immune system.
89101112Eligibility Criteria
This trial is for infants up to 1 year old with a new diagnosis of CD19 positive acute lymphoblastic leukemia or related conditions, with limited prior treatment. They must have more than 25% leukemia cells in their bone marrow and can have some previous short-term treatments like hydroxyurea or glucocorticoids.Participant Groups
The TINI 2 study aims to improve the initial TINI study by testing blinatumomab's effectiveness in clearing persistent leukemia. Blinatumomab is an immunotherapy that targets CD19 on the surface of leukemia cells, along with other drugs like Mercaptopurine and Methotrexate.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment9 Interventions
Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance.
Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Phoenix Children's HospitalPhoenix, AZ
Arkansas Children's HospitalLittle Rock, AR
Children's Hospital Los AngelesLos Angeles, CA
Valley Children's HospitalMadera, CA
More Trial Locations
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Who is running the clinical trial?
Tanja Andrea GruberLead Sponsor
Stanford UniversityLead Sponsor
Lucile Packard Children's Hospital FoundationCollaborator
Kura OncologyCollaborator
Kura Oncology, Inc.Industry Sponsor
AmgenIndustry Sponsor
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumCollaborator
Lucile Packard Foundation for Children's HealthCollaborator
References
Immunoglobulin repletion during blinatumomab therapy does not reduce the rate of secondary hypogammaglobulinemia and associated infectious risk. [2022]Blinatumomab has demonstrated efficacy in minimal residual disease (MRD) positive and relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) by inciting rapid and sustained B-cell depletion.
Short-course blinatumomab for refractory/relapse precursor B acute lymphoblastic leukemia in children. [2023]To evaluate the clinical efficacy and safety of a short course of blinatumomab in children with refractory or relapsed precursor B-cell acute lymphoblastic leukemia (R/R-BCP-ALL).
A Systematic Review of Blinatumomab in the Treatment of Acute Lymphoblastic Leukemia: Engaging an Old Problem With New Solutions. [2021]To assess the current literature for blinatumomab in the treatment of adult and pediatric B-cell acute lymphoblastic leukemia (ALL).
Blinatumomab for First-Line Treatment of Children and Young Persons With B-ALL. [2023]We tested whether blinatumomab (Blina) is effective as a toxicity-sparing alternative to first-line intensive chemotherapy in children and young persons (CYP) with B-ALL who were chemotherapy-intolerant or chemotherapy-resistant.
Blinatumomab following haematopoietic stem cell transplantation - a novel approach for the treatment of acute lymphoblastic leukaemia in infants. [2021]Blinatumomab with subsequent haematopoietic stem cell transplantation was applied in 13 infants with acute lymphoblastic leukaemia (ALL). Eight patients were treated in first remission due to slow clearance of minimal residual disease (MRD); one for MRD-reappearance after long MRD negativity, one for primary refractory disease and three during relapse treatment. In slow MRD responders, complete MRD response was achieved prior to transplantation, with an 18-month event-free survival of 75%. In contrast, only one of five patients with relapsed/refractory ALL is still in complete remission. These data provide a basis for future studies of immunotherapy in very high-risk infant ALL.
The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis. [2022]Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Despite its efficacy, it has also been associated with the development of potentially serious adverse events such as the cytokine release syndrome (CRS) and neurologic events. The present meta-analysis aimed to assess the safety profile of blinatumomab in terms of serious adverse events, CRS, and neurologic events (such as seizure and encephalopathy) in pediatric patients with B-cell ALL.
FDA Approval: Blinatumomab. [2021]On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R ALL). Blinatumomab is a recombinant murine protein that acts as a bispecific CD19-directed CD3 T-cell engager. The basis for the approval was a single-arm trial with 185 evaluable adults with R/R ALL. The complete remission (CR) rate was 32% [95% confidence interval (CI), 26%-40%], and the median duration of response was 6.7 months. A minimal residual disease response was achieved by 31% (95% CI, 25%-39%) of all patients. Cytokine release syndrome and neurologic events were serious toxicities that occurred. Other common (>20%) adverse reactions were pyrexia, headache, edema, febrile neutropenia, nausea, tremor, and rash. Neutropenia, thrombocytopenia, and elevated transaminases were the most common (>10%) laboratory abnormalities related to blinatumomab. A randomized trial is required in order to confirm clinical benefit.
Blinatumomab (Blincyto) for acute lymphoblastic leukemia. [2015]Blinatumomab (Blincyto) was effective in inducing a complete remission in 33% of patients with relapsed or refractory Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL). Grade 3 or 4 adverse effects occur frequently.
Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia. [2017]Patients with acute lymphocytic leukemia (ALL) often experience relapse of their disease following standard treatment. Blinatumomab (Blincyto®) is a newly approved option for inducing remission in individuals with relapsed or refractory Philadelphia chromosome-negative B-cell ALL.
A closer look at blinatumomab. [2018]On March 29, 2018, blinatumomab (Blincyto, Amgen) received an accelerated expanded approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in first or second complete remission (CR) and have minimal residual disease (MRD). Blinatumomab was first approved for use in adult patients (in December 2014) and later in pediatric patients (in September 2016) with relapsed or refractory Philadelphia chromosome (Ph)-negative B-cell precursor ALL; the approval was expanded in July 2017 to include patients with Ph-positive disease. The agent is a bispecific CD19-directed CD3 T-cell engager.
A Multidisciplinary Approach to Standardizing Processes for Blinatumomab Administration. [2017]Blinatumomab (Blincyto®) has received accelerated approval for treatment of relapsed or refractory acute lymphoblastic leukemia. This article describes the authors' experience with a multidisciplinary collaboration among nursing, pharmacy, prescribers, and support staff, which has proven to be key for safe administration. The approach can be applied to other institutions planning to use blinatumomab.
Children's Oncology Group AALL1331: Phase III Trial of Blinatumomab in Children, Adolescents, and Young Adults With Low-Risk B-Cell ALL in First Relapse. [2023]Blinatumomab, a bispecific T-cell engager immunotherapy, is efficacious in relapsed/refractory B-cell ALL (B-ALL) and has a favorable toxicity profile. One aim of the Children's Oncology Group AALL1331 study was to compare survival of patients with low-risk (LR) first relapse of B-ALL treated with chemotherapy alone or chemotherapy plus blinatumomab.