Clinical trial · Interventional
FIL Study on ABVD DD-DI as Upfront Therapy in HL.
A Randomized, Open-label, Multicenter, Phase III, 2-arm Study Comparing Efficacy and Tolerability of the Intensified Variant 'Dose-dense/Dose-intense ABVD' (ABVD DD-DI) With an Interim PET Response-adapted ABVD Program as Upfront Therapy in Advanced-stage Classical Hodgkin Lymphoma (HL).
NCT03159897CI-TRIAL-00093361completedPhase 3ClinicalTrials.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 FIL-Rouge is a randomized, open-label, multicenter, phase III, 2-arm study. The primary objective is to compare efficacy and tolerability of the intensified variant 'dose-dense/dose-intense ABVD' (ABVD DD-DI) with an interim PET response-adapted ABVD program as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL).
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Comparator arm
- description
- Patients will receive 2 courses of standard ABVD (ABVD-28, d1, d15, cycles of 28 days) and then proceed to interim PET/CT evaluation. Those with a PET-2-negative scan (score 1-3 on 5PS) will continue with additional 4 ABVD courses while those with a PET-2-positive (score 4-5) scan will be diverted towards an intensification phase with either escalated BEACOPP or HDT plus ASCR, according to the preference of the centre. Upon completion of treatment, patients will be categorized for response (Lugano2014) by comparing actual PET/CT imaging with baseline, whether 6 ABVD cycles or ABVDx2 + intensification phase with BEACOPP or HDT/ASCR. A salvage rescue program will be planned for patients with Stable (\<PR) or Progressive Disease. ISRT 30 Gy will be delivered to complete responders (5PS score 1-2-3) on the initial bulky site(s), to focal rests in case of CR scoring 3 on 5PS with a residual size ≥ 2.5 cm and to focal rests uptakes in the event of PR scoring 4 or 5, whichever is the size.
- interventionNames
- Drug: Doxorubicin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: Dacarbazine
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed classical HL * Previously untreated disease * Age 18-60 years * Ann Arbor stage IIB with extranodal involvement and/or mediastinal bulk, III and IV (Appendix A) * At least one target PET-avid bidimensionally assessable lesion * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 (Appendix B) * 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/1.72 m2 (Appendix C) * Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception * Life expectancy \> 6 months * Able to adhere to the study visit schedule and other protocol requirements * Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. * Access to PET-CT scans facilities qualified by FIL 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 (as defined by the updated Guidelines \[76\]), 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 related to impaired respiratory capacity due to airway compression by mediastinal masses 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 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 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 * 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.