Clinical trial · Observational
Circulating Tumor DNA Genotyping for Biological Monitoring of Patients Treated in the FIL-Rouge Clinical Trial
Circulating Tumor DNA Genotyping for Biological Monitoring of Patients with Advanced-stage Classical HL Receiving Upfront ABVD-based Chemotherapy. an Ancillary Study to the FIL-Rouge Phase III Trial
NCT05066555CI-TRIAL-00084211FIL-RougeBIOcompletedClinicalTrials.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)
Prospective, multicenter, non-interventional, biological study ancillary to FIL-Rouge clinical trial (NCT03159897) enrolling patients affected by Advanced-stage Hodgkin Lymphoma, ABVD-based upfront treatment in 19 centers in Italy part of Fondazione Italiana Linfomi.
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 |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Advanced-stage Hodgkin Lymphoma patients (1)
- description
- All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Comparator arm).
- label
- Advanced-stage Hodgkin Lymphoma patients (2)
- description
- All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Experimental arm).
Primary outcomes (1)
- measure
- Complete Response Rate (CRR)
- timeFrame
- The endpoint will be assessed from the beginning of the study up to 76 months
- description
- Complete Response Rate (CRR) is defined as the proportion of patients achieving a Complete Remission (CR) at the end of treatment;
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: FIL ROUGE INCLUSION CRITERIA * Histologically confirmed classical HL * Previously untreated disease * Age 18-60 years * Ann Arbor stage IIB with extranodal involvement and/or bulk, III and IV * At least one target PET-avid bidimensionally assessable lesion * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2 * Adequate organ and marrow function as defined below: * Absolute neutrophil count \>1,0 x109/L, platelets \>75 x109/L * Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome * Aspartate Transaminase and Alanine Transaminase (AST/ALT) \<3 X institutional Upper Limits of Normality (ULN) * Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2 * Females of childbearing must have a negative pregnancy test under medical supervision even if patients had been using effective contraception * Life expectancy \> 6 months * Able to adhere to the study visit schedule and other protocol requirements * Signed (or legally acceptable representatives must sign) informed consent indicating that patients understand the purpose of and procedures required for the study and are willing to participate in the study. * Access to PET-CT (Positron Emission Tomography/Computed Tomography) scans facilities qualified by FIL Exclusion Criteria: FIL ROUGE EXCLUSION CRITERIA * Nodular Lymphocyte Predominant HL * Ann Arbor stage IIB without extranodal involvement and/or mediastinal bulky * Prior chemotherapy or radiation therapy * Pregnant or lactating females * Known hypertension, cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography. * Abnormal QTc interval prolonged (\>450 msec in males; \>470 msec in women) * Diffusion lung capacity for CO (DLCO)and/or Forced expiratory volume in the 1st second (FEV1) tests \<50% of predicted not due to mediastinal compression or parenchymal lymphoma * Known cerebral or meningeal disease (HL or any other etiology) * Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following: basal cells carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast and prostate cancer with the TNM stage of T1a or T1b * Uncontrolled infectious disease * Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (Hepatitis B core) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided (Lamivudine) * Uncompensated diabetes * Refusal of adequate contraception * Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.