Hodgkin Lymphoma
Conditions
Keywords
Hodgkin Lymphoma, ABVD treatment, ancillary, ctDNA, cHL, FIL-Rouge, PFS, Response Rate
Brief summary
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.
Detailed description
The FIL-Rouge design provides an ideal environment for validating the liquid biopsy in Classical Hodgkin lymphoma (cHL), since one arm of the study will utilize a PET/CT-adapted strategy (Positron Emission Tomography/Computed Tomography)for treatment, while the second arm will be devoid of any PET/CT-adaptation of therapy. Also, estimating prospectively differences in residual disease between the two study arms of the FIL-Rouge will provide an important biologic tool to validate the concept of dose-intensification within the ABVD therapeutic platform. This study aims at the prospective validation of the concept of the liquid biopsy as a biomarker for disease response assessment in cHL. The patients enrolled in the FIL-Rouge clinical trial at the centers participating in this study and consenting to the biological study FIL-RougeBIO will be considered for this study. After providing written informed consent, relevant patients will be evaluated for detecting cancer gene mutations in ctDNA (Circulating Tumor DNA) for measuring residual disease. All clinical data useful for data analyses of this study will derive from the FIL-Rouge clinical trial. Given the non-interventional design of the study, project participants will not have immediate potential benefits.The enrollment in FIL-RougeBIO will parallel the original protocol until reaching the 500 programmed patients. The results of this study could benefit future patients with the same condition.
Interventions
None listed
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | The endpoint will be assessed from the beginning of the study up to 76 months | Complete Response Rate (CRR) is defined as the proportion of patients achieving a Complete Remission (CR) at the end of treatment; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (Positron Emission Tomography/Computed Tomography) | The endpoint will be assessed from the beginning of the study up to 76 months | Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios accuracy); The endpoint will be evaluated through specific timepoints. |
| Progression Free Survival (PFS) with at least three years of follow up | The endpoint will be assessed from the beginning of the study up to 76 months | PFS is defined as the interval elapsing from randomization until lymphoma progression/relapse or death as a result of any cause. |
Countries
Italy
Outcome results
None listed