Acute Lymphoblastic Leukemia, Pediatric
Conditions
Keywords
acute lymphoblastic leukemia, chemotherapy, antineoplastic agents, varicella vaccine, chickenpox vaccine, pneumococcal vaccines, measles vaccine
Brief summary
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 100 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
Interventions
OTHERObservational only: Serology and flow cytometry for ALL cohort participants
Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery
OTHERObservational only: Infection rates
Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.
Sponsors
Children's Hospital of Philadelphia
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 31 Years
Healthy volunteers
No
Inclusion criteria
* Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older * Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months * Three years of age or older at time of enrollment
Exclusion criteria
* Diagnosis of infant ALL * Evidence of disease relapse * History of primary immunodeficiency (except related to Down Syndrome) * History of a stem cell transplant or cellular immunotherapy * History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy | 1 year | Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint | 1 year | The seroprevalence proportions for measles antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy. |
| Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint | 1 year | The seroprevalence proportions for varicella antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy. |
| Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint | 1 year | The seroprevalence proportions for pneumococcal antibodies (23 serotypes) will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian T Fisher, DO MSCE MPH
Children's Hospital of Philadelphia
Participant flow
Recruitment details
Recruitment period: September 2022 - October 2024 Participating sites: Six pediatric hemotology/oncology centers in the U.S. Patients completing chemotherapy for acute lymphoblastic leukemia during the study period screened for eligibility.
Pre-assignment details
This was an observational study with only one study arm for enrollment of participants recently completing chemotherapy for acute lymphoblastic leukemia.
Baseline characteristics
| Characteristic | — |
|---|---|
| Acute Lymphoblastic Leukemia Subtype and Risk Classification High-risk B-cell Acute Lymphoblastic Leukemia | 27 Participants |
| Acute Lymphoblastic Leukemia Subtype and Risk Classification Standard-risk B-cell Acute Lymphoblastic Leukemia | 47 Participants |
| Acute Lymphoblastic Leukemia Subtype and Risk Classification T-cell Acute Lymphoblastic Leukemia | 15 Participants |
| Age, Continuous | 8.7 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 89 |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 3 / 89 |
Outcome results
None listed