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

This trial does not accept healthy volunteers

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 population

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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

300 Participants

are grouped into 2 trial groups

Group A: Cases

Group B: Controls

Trial outcomes

Primary outcomes

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

Time frame

>/= 6 months following the completion of blinatumomab therapy

Secondary outcomes

Proportion of participants who achieve seroconversion (i.e., transition from non-protective to protective antibody titers)

Will assess whether revaccination restores protective immunity in participants with non-protective titers after blinatumomab

Time frame

within 6 months following revaccination

Other outcomes

Comparison of protective titer rates between Case and Control groups

Comparison of protective titer rates between participants who received blinatumomab and those who did not, adjusting for age, treatment intensity, and time since last vaccine dose

Time frame

>/= 6 months following the completion of therapy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arkansas Children's Hospital Research Institute

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov

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