Health Trials

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

ConditionsB-Cell ALLB-Cell Acute Lymphoblastic LeukaemiaB-Cell Lymphoblastic LeukemiaB-Cell Lymphoblastic Leukemia/LymphomaB-cell Acute Lymphoblastic Leukemia (B-ALL)B-cell Acute Lymphoblastic LeukemiaB-cell Childhood Acute Lymphoblastic LeukemiaB-cell Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-23
SponsorArkansas Children's Hospital Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Relapsed/refractory disease at any time

Received or will require a bone marrow transplant and/or cellular therapy

Pregnancy

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Arkansas Children's Hospital Research Institute

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov