EUCTR2020-002017-18-FR
Active, not recruiting
Phase 1
Clinical trial assessing the immunogenicity of an anti-pneumococcal combined vaccination strategy in adult patients treated for an acute leukemia or a lymphoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU DE POITIERS
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patient \= 18 year\-old.
- •\- AND medical follow\-up in hematology unit
- •\- AND had received a first course of chemotherapy for acute myeloblastic leukemia without PML\-RARa and no planned allogeneic hematopoietic stem cell transplantation or for diffuse large B cell lymphoma or for follicular lymphoma
- •\- Life expectancy \> 6 months
- •\- Having signed the consent form.
- •\- Having an health insurance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
Exclusion Criteria
- •Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti\-CD20 antibodies in the chemotherapy protocol.
- •\- Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago).
- •\- Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy.
- •\- Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion.
- •\- Allogeneic hematopoietic stem cell transplantation planned in the following 3 months after the first chemotherapy course.
- •\- Curative anticoagulation within 7 days before vaccination.
- •\- Major blood clotting disorders preventing intramuscular injection.
- •\- Medical history of anaphylactic reaction to vaccination.
- •\- Known allergy to one of the vaccine components.
- •\- Involvement to another vaccine biomedical research.
Outcomes
Primary Outcomes
Not specified
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