Intrathecal Chemoprophylaxis for Acute Lymphoblastic Leukemia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Northside Hospital, Inc.
Disqualifiers: CNS disorders, Prior blinatumomab, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Blinatumomab for treating acute lymphoblastic leukemia?
Blinatumomab has shown promising results in treating relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) by activating the body's immune system to attack cancer cells. Studies have demonstrated that it can improve survival rates and reduce the amount of cancer left in the body compared to traditional chemotherapy, especially in children and young adults.
12345Is intrathecal chemoprophylaxis for acute lymphoblastic leukemia safe?
Blinatumomab, used for treating acute lymphoblastic leukemia, has been shown to be generally safe, but it can cause some immune-related side effects. It is considered a safer option for patients who cannot tolerate traditional chemotherapy, although it requires careful monitoring by medical professionals.
46789How is the drug Blinatumomab unique in treating acute lymphoblastic leukemia?
Blinatumomab is unique because it is a bispecific antibody that engages T cells to target and destroy leukemia cells, offering a favorable toxicity profile compared to standard chemotherapy, especially for relapsed or refractory cases.
15101112Eligibility Criteria
Adults with B-cell Acute Lymphoblastic Leukemia who are about to start their first cycle of blinatumomab can join. They must have good kidney and liver function, be HIV negative, not pregnant if applicable, and without active infections or other serious health issues that could interfere with the study.Inclusion Criteria
I am starting blinatumomab for my relapsed or MRD-positive B-cell ALL.
Negative serum pregnancy test, if applicable
My kidney and liver are working well.
+2 more
Exclusion Criteria
I do not have any infections or conditions that could affect the study.
My acute lymphoblastic leukemia has spread to my brain or spinal cord.
I cannot receive methotrexate injections into my spine.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intrathecal Chemotherapy
Participants receive intrathecal chemotherapy before and during blinatumomab to prevent neurotoxicity
4 weeks
Blinatumomab Therapy
Participants receive blinatumomab therapy with monitoring for neurotoxicity and cytokine release syndrome
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing a new schedule for giving intrathecal chemotherapy (directly into the spinal fluid) alongside blinatumomab to see if it reduces brain-related side effects while still fighting leukemia effectively.
1Treatment groups
Experimental Treatment
Group I: Intrathecal chemotherapy before blinatumomabExperimental Treatment2 Interventions
Blinatumomab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Blincyto for:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- High-risk first relapse BCP-ALL
🇺🇸 Approved in United States as Blincyto for:
- 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
Research Locations NearbySelect from list below to view details:
Northside HospitalAtlanta, GA
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Who Is Running the Clinical Trial?
Northside Hospital, Inc.Lead Sponsor
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.
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 in Pediatric Acute Lymphoblastic Leukemia-From Salvage to First Line Therapy (A Systematic Review). [2021]Acute lymphoblastic leukemia is by far the most common malignancy in children, and new immunotherapeutic approaches will clearly change the way we treat our patients in future years. Blinatumomab is a bispecific T-cell-engaging antibody indicated for the treatment of relapsed/refractory acute lymphoblastic leukemia (R/R-ALL). The use of blinatumomab in R/R ALL has shown promising effects, especially as a bridging tool to hematopoietic stem cell transplantation. For heavily pretreated patients, the response to one or two cycles of blinatumomab ranges from 34% to 66%. Two randomized controlled trials have very recently demonstrated an improved reduction in minimal residual disease as well as an increased survival for patients treated with blinatumomab compared to standard consolidation treatment in first relapse. Current trials using blinatumomab frontline for high-risk patients or as a consolidation treatment post-transplant will show whether efficacy is even higher in less heavily pretreated patients. Due to the distinct pattern of adverse events compared to high-dose conventional chemotherapy, blinatumomab could play an important role for patients with a risk for severe chemotherapy-associated toxicities. This systematic review discusses all published results for blinatumomab in children as well as all ongoing clinical trials.
Blinatumomab: enlisting serial killer T-cells in the war against hematologic malignancies. [2023]The approval of blinatumomab signals the long awaited arrival of immunotherapy for acute lymphoblastic leukemia (ALL). Previous options for relapsed or refractory disease were restricted to cytotoxic chemotherapy with limited efficacy and significant toxicity. Through an innovative mechanism of action, blinatumomab stimulates a polyclonal antitumor T-cell response, yielding unprecedented single agent efficacy in the relapsed/refractory setting. Success comes at the cost of immunological toxicities rarely encountered with previous therapies and challenging administration logistics requiring clinical expertise.
Effect of Postreinduction Therapy Consolidation With Blinatumomab vs Chemotherapy on Disease-Free Survival in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. [2021]Standard chemotherapy for first relapse of B-cell acute lymphoblastic leukemia (B-ALL) in children, adolescents, and young adults is associated with high rates of severe toxicities, subsequent relapse, and death, especially for patients with early relapse (high risk) or late relapse with residual disease after reinduction chemotherapy (intermediate risk). Blinatumomab, a bispecific CD3 to CD19 T cell-engaging antibody construct, is efficacious in relapsed/refractory B-ALL and has a favorable toxicity profile.
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).
Blinatumomab: A First-in-Class Bispecific T-Cell Engager for Precursor B-Cell Acute Lymphoblastic Leukemia. [2018]To review the clinical pharmacology, efficacy, and safety of blinatumomab for the treatment of pediatric and adult precursor B-cell acute lymphoblastic leukemia (B-ALL).
Efficacy and Safety of Blinatumomab for the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia: A Systemic Review and Meta-Analysis. [2023]The aim was to evaluate the efficacy and safety of blinatumomab monotherapy for the treatment of relapsed/refractory acute lymphoblastic leukemia (R/R B-ALL).
Blinatumomab as a bridge to further therapy in cases of overwhelming toxicity in pediatric B-cell precursor acute lymphoblastic leukemia: Report from the Israeli Study Group of Childhood Leukemia. [2020]Tremendous progress in the therapy of pediatric acute lymphoblastic leukemia (ALL) has been achieved through combination cytotoxic chemotherapy, leading to high cure rates, at the cost of significant life-threatening toxicity. The bispecific T-cell engager blinatumomab, recently approved for relapsed/refractory ALL, has a unique nonmyelotoxic toxicity profile. As blinatumomab causes B-cell depletion, the safety of its use during severe chemotherapy-induced toxicity is unclear. We report 11 pediatric patients with ALL, treated with blinatumomab following overwhelming chemotherapy-associated toxicity, with recovery of all patients and successful bridging to further antileukemia therapy. Blinatumomab can be considered for rare patients who cannot tolerate cytotoxic therapy.
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.
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.
Blinatumomab in Children and Adolescents with Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia: A Real-Life Multicenter Retrospective Study in Seven AIEOP (Associazione Italiana di Ematologia e Oncologia Pediatrica) Centers. [2022]Five-year event-free survival in pediatric B-cell precursor acute lymphoblastic leukemia (BCP-ALL) currently exceeds 80-85%. However, 15-20% of patients still experience a relapsed/refractory disease. From 1 January 2015 to 31 December 2020, thirty-nine patients, 0-21 years old with r/r BCP-ALL were treated with blinatumomab with the aim of inducing remission (n = 13) or reducing MRD levels (n = 26) in the frame of different multiagent chemotherapy schedules, in seven AIEOP centers. Patients were treated in compassionate and/or off-label settings and were not enrolled in any controlled clinical trials. Treatment was well tolerated; 22 (56.4%) patients reported adverse events (AE) on a total of 46 events registered, of which 27 (58.7%) were ≤2 grade according to CTCAE. Neurological AEs were 18 (39.1%); only two patients required transient blinatumomab discontinuation. Complete remission (CR) rate was 46% for the 13 patients treated with ≥5% blasts and 81% PCR/FC MRD negativity in the 26 patients with blasts < 5%. Median relapse-free survival was 33.4 months (95% CI; 7.5-59.3); median overall survival was not reached over a mean follow-up of 16 months. In our study, as in other real-life experiences, blinatumomab proved to be effective and well-tolerated, able to induce a high rate of CR and MRD negativity.