A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
BOOSTER
Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
1 other identifier
observational
300
1 country
2
Brief Summary
The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. The main study aims are:
- Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL/Ly who have received blinatumomab.
- To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity. Researchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2026
CompletedFirst Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
February 25, 2026
February 1, 2026
2 years
February 13, 2026
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with protective serum antibody titers
Participants will have antibody titers evaluated as standard of care. Titers evaluated include: tetanus, Haemophilus influenzae type b \[Hib\], Hepatitis B, Streptococcus pneumoniae \[pneumococcal\], Varicella Zoster Virus, and Measles
>/= 6 months following the completion of blinatumomab therapy
Secondary Outcomes (1)
Proportion of participants who achieve seroconversion (i.e., transition from non-protective to protective antibody titers)
within 6 months following revaccination
Other Outcomes (1)
Comparison of protective titer rates between Case and Control groups
>/= 6 months following the completion of therapy
Study Arms (2)
Cases
Participants who have received blinatumomab
Controls
Participants who have not received blinatumomab
Eligibility Criteria
Potential participants will be identified through referrals and from medical records. Prospective participants are those who have been captured prior to starting chemotherapy, and retrospective participants are those who have been captured after starting chemotherapy or have finished chemotherapy within the previous 12 months.
You may qualify if:
- Diagnosis of B-lineage acute lymphoblastic leukemia/lymphoma
- ≥1 year old and up to 21 years old at diagnosis
- Informed consent provided, and if applicable, child assent provided
- Must have received all vaccinations routinely administered during first year of life
You may not qualify if:
- Relapsed/refractory disease at any time
- Received or will require a bone marrow transplant and/or cellular therapy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Arkansas Children's
Little Rock, Arkansas, 72202, United States
Arkansas Children's Northwest
Springdale, Arkansas, 72762, United States
Related Publications (11)
Carpenter PA, Englund JA. How I vaccinate blood and marrow transplant recipients. Blood. 2016;127(23):2824-2832.
BACKGROUNDClose E, McConnell G, Cross S, Bradford JL. Immunogenicity of Childhood Vaccines after Pediatric Cancer. AFP. 2020;102(11).
BACKGROUNDFoundation LR. B-cell Acute Lymphoblastic Leukemia [Internet]. Available from: https://leukemiarf.org/leukemia/acute-lymphoblastic-leukemia/b-cell-lymphoblastic-leukemia
BACKGROUNDKyriakidis I, Mantadakis E, Stiakaki E, Groll AH, Tragiannidis A. Infectious Complications of Targeted Therapies in Children with Leukemias and Lymphomas. Cancers (Basel). 2022 Oct 14;14(20):5022. doi: 10.3390/cancers14205022.
PMID: 36291806BACKGROUNDToret E, Yel SE, Suman M, Duzenli Kar Y, Ozdemir ZC, Dinleyici M, Bor O. Immunization status and re-immunization of childhood acute lymphoblastic leukemia survivors. Hum Vaccin Immunother. 2021 Apr 3;17(4):1132-1135. doi: 10.1080/21645515.2020.1802975. Epub 2020 Sep 3.
PMID: 32882157BACKGROUNDCetin M, Gumy-Pause F, Gualtieri R, Posfay-Barbe KM, Blanchard-Rohner G. Vaccine Immunity in Children After Hematologic Cancer Treatment: A Retrospective Single-center Study. J Pediatr Hematol Oncol. 2024 Jan 1;46(1):e51-e59. doi: 10.1097/MPH.0000000000002774. Epub 2023 Nov 3.
PMID: 37922437BACKGROUNDGupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2025 Feb 27;392(9):875-891. doi: 10.1056/NEJMoa2411680. Epub 2024 Dec 7.
PMID: 39651791BACKGROUNDWang K, Wei G, Liu D. CD19: a biomarker for B cell development, lymphoma diagnosis and therapy. Exp Hematol Oncol. 2012 Nov 29;1(1):36. doi: 10.1186/2162-3619-1-36.
PMID: 23210908BACKGROUNDKeskin Yildirim Z, Buyukavci M. Assessment of Humoral Immunity to Hepatitis B, Measles, Rubella, and Mumps in Children After Chemotherapy. J Pediatr Hematol Oncol. 2018 Mar;40(2):e99-e102. doi: 10.1097/MPH.0000000000001072.
PMID: 29309372BACKGROUNDLehrnbecher T, Schubert R, Allwinn R, Dogan K, Koehl U, Gruttner HP. Revaccination of children after completion of standard chemotherapy for acute lymphoblastic leukaemia: a pilot study comparing different schedules. Br J Haematol. 2011 Mar;152(6):754-7. doi: 10.1111/j.1365-2141.2010.08522.x. Epub 2011 Jan 20.
PMID: 21250973BACKGROUNDAnafy A, Gilad G, Michaan N, Elhasid R, Rosenfeld-Kaidar H, Arad-Cohen N, Cohen MS, Shachor-Meyouhas Y, Grisaru-Soen G. Revaccination of children with acute lymphoblastic leukemia following completion of chemotherapy. Pediatr Blood Cancer. 2023 Jun;70(6):e30321. doi: 10.1002/pbc.30321. Epub 2023 Apr 10.
PMID: 37036274BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Appell, MD
Arkansas Children's Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
January 13, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with other researchers, and each participating site has access to only their center's data; however, aggregated data will be be included in future publications and will be made available to participating centers following study completion.