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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT07422337
Status
Recruiting
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Conditions

  • B-Cell ALL
  • B-Cell Acute Lymphoblastic Leukaemia
  • B-Cell Lymphoblastic Leukemia
  • B-Cell Lymphoblastic Leukemia/Lymphoma
  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Acute Lymphoblastic Leukemia (B-ALL)
  • B-cell Childhood Acute Lymphoblastic Leukemia
  • B-cell Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - 23 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Cases
    Participants who have received blinatumomab
  • Arm: Controls
    Participants who have not received blinatumomab

Primary Outcome Measure

Proportion of participants with protective serum antibody titers [ Time Frame: >/= 6 months following the completion of blinatumomab therapy ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arkansas Children'sLittle RockArkansas72202
Stephanie Thomas, RN
[email protected]
501-364-3820
Lauren Appell, MD
501-364-1494
Lauren Appell, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's NorthwestSpringdaleArkansas72762
Cristyn Branstetter, MD
[email protected]
479-770-5921
Cristyn Branstetter, MD (PRINCIPAL_INVESTIGATOR)

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