Clinical trial · Observational
Signal Detection in Monoclonal and New Agents in Lymphoma
Detection of Long Term Toxicity of Monoclonal Agents Combined With Chemotherapy in Non-Hodgkin Lymphoma - the SIMONAL Project
- 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)
Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) led for the first time to decline of the specific mortality. After treatment, patients with NHL experienced elevated risks for therapy-related leukemia, several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases which impact on quality of life. However little is known concerning long-term toxicity of this class of new agents so called "targeted drugs" such as anti-CD20. The primary objective of this cohort study is to estimate long term toxicity in NHL patients (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare drugs consumption to that of controls (i.e. external analysis).
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Health problems
- timeFrame
- Day 0
- description
- Disproportionate reporting of health problems in relation with neuro-psychiatric troubles, cardio-vascular diseases, digestive tract diseases etc.
- measure
- health care use
- timeFrame
- Day 0
- description
- Disproportionate reporting of health care use (drug consumption, hospitalization, doctors consultations)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Initial diagnosis of histologically confirmed CD20+ diffuse large B-cell Lymphoma, De novo transformed follicular lymphoma (FL) is allowed * Follicular lymphoma * Mantle cell lymphoma * Previously untreated with chemo- or radiotherapy * Include in LYSA trial * Age 18-90 years Exclusion Criteria: * Any other type of lymphoma. * Previous treatment with chemotherapy or radiation therapy * Contraindication to any drug contained in the chemotherapy regimen * Previously known HIV positive serology * Active hepatitis B or C * Prior history of malignancies other than lymphoma within 3 years
References
Publications (0)
Data not yet available