Clinical trial · Observational
Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies
Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Hematologic Malignancies and Associated Precursor Conditions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
D1. Primary Objective: 1\. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies D2. Secondary Objectives: 1. Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies 2. Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination 3. Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA 4. Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Monoclonal B-Cell Lymphocytosis | Monoclonal B-Cell Lymphocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Humoral Immunogenicity
- timeFrame
- Assessed 14 days following the second dose of the vaccine
- description
- Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
- measure
- Cellular Immunogenicity
- timeFrame
- Assessed 14 days following the second dose of the vaccine
- description
- Number of participants who have a SARS-CoV-2 specific memory B cell ELISPOT response
- measure
- Cellular Immunogenicity
- timeFrame
- Assessed 14 days following the second dose of the vaccine
- description
- Number of participants who have a SARS-CoV-2 specific IFNγ ELISPOT T cell response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must not have received any prior COVID-19 vaccination 2. Patients must have any one of the following diagnosis: a. Monoclonal B-cell lymphocytosis b. Chronic lymphocytic leukemia/small lymphocytic lymphoma c. B-cell Non-Hodgkin's lymphoma: i. Follicular lymphoma ii. Mantle cell lymphoma iii. Diffuse large B-cell lymphoma iv. Marginal zone lymphoma v. Burkitt lymphoma vi. Double hit/triple hit lymphoma vii. Lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia d. Hodgkin lymphoma Exclusion Criteria: 1. Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to registration 2. Prior chemotherapy, immunotherapy or oral agent therapy that was completed \>12 months prior to enrollment. NOTE: patients who are on oral agents for the treatment of their underlying malignancy will be allowed. Some of these medication classes include Bruton tyrosine kinase inhibitor (BTKi), BCL2 antagonists, PI3 kinase inhibitors, immunomodulatory agents, among others. Please contact the Principal Investigator for any clarification about these medications.
References
Publications (0)
Data not yet available