Clinical trial · Interventional
Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL
Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
NCT04862806CI-TRIAL-00053940unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COVID-19 serology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Israel CLL study group
- description
- BNT162b2 mRNA vaccine
- interventionNames
- Diagnostic Test: COVID-19 serology
Primary outcomes (2)
- measure
- Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
- timeFrame
- 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
- description
- Answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire on the same clinic visit when blood is drawn for serologic tests.
- measure
- Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL was according to the IWCLL criteria * All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer). Exclusion Criteria: * previous covid19 virus infection
References
Publications (1)
- DERIVEDHerishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085. PMID 34861036