Recruiting

B-ALL with Blinatumomab

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT07422337

Conditions

B-Cell ALL

B-Cell Acute Lymphoblastic Leukaemia

B-Cell Lymphoblastic Leukemia

B-Cell Lymphoblastic Leukemia/Lymphoma

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Eligibility Criteria

Sex: All

Age: 1 - 23

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

B-Cell ALL

B-Cell Acute Lymphoblastic Leukaemia

B-Cell Lymphoblastic Leukemia

B-Cell Lymphoblastic Leukemia/Lymphoma

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Study ID

NCT07422337

Start date

Jan 13, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 23

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Cases

Participants who have received blinatumomab

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 and Locations

Central contacts

Lauren Appell, MD

501-364-1494leappell@uams.edu

Stephanie Thomas, RN

501-364-3820

Locations

Arkansas Children's

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Stephanie Thomas, RN

501-364-3820chamnesssl@archildrens.org

Lauren Appell, MD

501-364-1494

Principal Investigator:

Lauren Appell, MD

Arkansas Children's Northwest

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Cristyn Branstetter, MD

479-770-5921CBranstetter@uams.edu

Principal Investigator:

Cristyn Branstetter, MD

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • vaccines
  • cancer
  • blinatumomab
  • immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2026-02-25.