Clinical trial · Observational
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
Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Acute Lymphoblastic Leukaemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | B Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| B-Cell ALL | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Childhood Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| B-Cell Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-Cell Lymphoblastic Leukemia/Lymphoma | B Lymphoblastic Leukemia/Lymphoma |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Participants who have received blinatumomab
- label
- Controls
- description
- Participants who have not received blinatumomab
Primary outcomes (1)
- measure
- Proportion of participants with protective serum antibody titers
- timeFrame
- >/= 6 months following the completion of blinatumomab therapy
- description
- 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
Secondary outcomes (1)
- measure
- Proportion of participants who achieve seroconversion (i.e., transition from non-protective to protective antibody titers)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Relapsed/refractory disease at any time * Received or will require a bone marrow transplant and/or cellular therapy * Pregnancy
References
Publications (11)
- BACKGROUNDCarpenter PA, Englund JA. How I vaccinate blood and marrow transplant recipients. Blood. 2016 Jun 9;127(23):2824-32. doi: 10.1182/blood-2015-12-550475. Epub 2016 Apr 5. PMID 27048212
- BACKGROUNDClose E, McConnell G, Cross S, Bradford JL. Immunogenicity of Childhood Vaccines after Pediatric Cancer. Am Fam Physician. 2020 Dec 1;102(11):Online. No abstract available. PMID 33252910
- 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 36291806
- BACKGROUNDToret 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 32882157
- BACKGROUNDCetin 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 37922437
- BACKGROUNDGupta 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.