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| ID | Type | Description | Link |
|---|---|---|---|
| 61366 | Other Grant/Funding Number | Merck Sharp and Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children, adolescents, and young adults who recently completed ALL treatment | This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational only: Serology and flow cytometry for ALL cohort participants | Other | Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Children, adolescents, and young adults receiving care at a participating pediatric oncology/hematology center who recently completed or will soon complete treatment for acute lymphoblastic leukemia
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| Name | Affiliation | Role |
|---|---|---|
| Brian T Fisher, DO MSCE MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Helen DeVos Children's Hospital |
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This was an observational study with only one study arm for enrollment of participants recently completing chemotherapy for acute lymphoblastic leukemia.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia | This group includes survivors of acute lymphoblastic leukemia between ages 3 and 31 who completed chemotherapy for acute lymphoblastic leukemia within +/- 3 months of the time of study enrollment and were followed until one year off-therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia | This group includes survivors of acute lymphoblastic leukemia between ages 3 and 31 who completed chemotherapy for acute lymphoblastic leukemia within +/- 3 months of the time of study enrollment and were followed until one year off-therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy | 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. | Analyzed 88 total participants; 1 participant lost to follow-up between enrollment and first post-enrollment study encounter. | Posted | Number | Events per person-year | 1 year |
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From enrollment to end of follow up, approximately 1 year
This study was observational in nature. Participants were monitored for death, relapse of acute lymphoblastic leukemia, or diagnosis of secondary malignancy during the follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia | This group includes survivors of acute lymphoblastic leukemia between ages 3 and 31 who completed chemotherapy for acute lymphoblastic leukemia within +/- 3 months of the time of study enrollment and were followed until one year off-therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse of acute lymphoblastic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Participants were monitored for relapse of acute lymphoblastic leukemia and censored at the time of relapse diagnosis. |
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This study has several limitations. Because research blood draws were timed with clinical laboratory draws at off-therapy visits, only patients with consistent follow-up were included in the vaccine titer data. Similarly, for infection incidence rates, only patients who consistently followed up and participated in study encounters were captured, meaning that some infections - perhaps among patients more likely to be ill - may have been missed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Morgan Hammershaimb | Children's Hospital of Philadelphia | 267-426-9727 | zalotm@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2025 | Dec 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Serum, peripheral blood mononuclear cells
| Observational only: Infection rates | Other | Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy. |
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| 1 year |
| Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint | 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. | 1 year |
| Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint | 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. | 1 year |
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| CHRISTUS Children's (Affiliate of Baylor College of Medicine) | San Antonio | Texas | 78207 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Acute Lymphoblastic Leukemia Subtype and Risk Classification | Count of Participants | Participants |
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| Age, Continuous | Age at Study Enrollment in Years | Median | Inter-Quartile Range | Years |
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| Age, Continuous | Age at Diagnosis of Acute Lymphoblastic Leukemia in Years | Age at which study participants were first diagnosed with acute lymphoblastic leukemia. | Median | Inter-Quartile Range | Years |
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| Secondary | Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint | 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. | For each timepoint, only patients with (A) any history of measles vaccine prior to chemotherapy and NO history of measles vaccine after chemotherapy and (B) serum available for testing at the timepoint are included in this analysis. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint | 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. | For each timepoint, participants with (A) any history of varicella vaccine prior to chemotherapy and NO history of varicella vaccine after chemotherapy and (B) serum available for testing at the timepoint are included in the analysis. | Posted | Count of Participants | Participants | 1 year |
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|
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| Secondary | Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint | 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. | Patients with any history of pneumococcal vaccine and serum available for testing at each timepoint were included. | Posted | Mar 2026 | Count of Participants | Participants | 1 year |
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| 0 |
| 89 |
| 3 |
| 89 |
| 0 |
| 89 |
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| Diagnosis of secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Measles-specific Immunoglobulin-G Level Indicative of Seroprotection at 12 Months Off-therapy |
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| Varicella-specific Immunoglobulin-G Level Indicative of Seroprotection at 12 Months Off-therapy |
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| Negative Titers |
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| Patients with Positive Titers to > 50% of Pneumococcal Vaccine Serotypes at 6 Months Off-therapy |
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| Patients with Positive Titers to > 50% of Pneumococcal Vaccine Serotypes at 12 Months Off-therapy |
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