Clinical trial · Interventional
Low Grade Lymphoma
Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
NCT01698866CI-TRIAL-00022602EVACC-BunknownPhase 4ClinicalTrials.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)
The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.
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 |
|---|---|---|---|
| Indolent Lymphoproliferative Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaccin GenHevac B Pasteur | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vaccin GenHevac B Pasteur
- description
- vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6
- interventionNames
- Biological: Vaccin GenHevac B Pasteur
Primary outcomes (1)
- measure
- Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
- timeFrame
- Month 7
Secondary outcomes (8)
- measure
- - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
- timeFrame
- Month 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor burden * No indication of chemotherapy during the seven months of the vaccination protocol. HBV serology negative for HBsAg / Ab HBs / HBc Ab. * No history of vaccination against hepatitis B. Exclusion Criteria: * Indication of immediate chemotherapy. * At least one HBV positive serologic marker . * History of vaccination against HBV. * Known neurodegenerative disease. * Pregnancy. * Febrile infection untreated. * Known allergy to any vaccine component.
References
Publications (0)
Data not yet available
No reference posted for this study.