Clinical trial · Interventional
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma
Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study
NCT02247869CI-TRIAL-00031612completedPhase 2ClinicalTrials.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, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dose dense ABVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose dense ABVD
- description
- 1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
- interventionNames
- Drug: dose dense ABVD
Primary outcomes (2)
- measure
- Feasibility
- timeFrame
- After 4 dd-ABVD cycles (12 weeks after starting treatment)
- description
- Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
- measure
- Activity
- timeFrame
- After 2 dd-ABVD cycles (6 week after starting treatment)
- description
- Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 years * Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky. * Previously untreated * ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2 * Staging with FDG-PET (fluorodeoxyglucose positron emission tomography) * Written informed consent * Adequate liver and renal function (total serum bilirubin \< 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine \< 2.5 x ULN) Exclusion Criteria: * Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease. * Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl) * Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years * Patients with a known history of HIV seropositivity * Active HCV infection (PCR + ; AST\> 1.5-2x UN) * Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months. * Negative pregnancy test at baseline is required (serum β HCG). * Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment * Nodular lymphocyte prevalence histological subtype
References
Publications (1)
- DERIVEDSantoro A, Mazza R, Spina M, Califano C, Specchia G, Carella M, Consoli U, Palombi F, Musso M, Pulsoni A, Kovalchuk S, Bonfichi M, Ricci F, Fabbri A, Liberati AM, Rodari M, Giordano L, Chimienti E, Balzarotti M, Sorasio R, Gallamini A, Ghiggi C, Ciammella P, Ricardi U, Chauvie S, Carlo-Stella C, Merli F. Dose-dense ABVD as first-line therapy in early-stage unfavorable Hodgkin lymphoma: results of a prospective, multicenter double-step phase II study by Fondazione Italiana Linfomi. Ann Hematol. 2021 Oct;100(10):2547-2556. doi: 10.1007/s00277-021-04604-x. Epub 2021 Jul 30. PMID 34327561