Clinical trial · Interventional
Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma
Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)
NCT01251107CI-TRIAL-00018827completedPhase 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 choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm B
- description
- BEACOPP (Bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) for 4 escalated cycles followed by 4 standard cycles
- interventionNames
- Drug: Bleomycin
- Drug: Etoposide
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Procarbazine
- Drug: Prednisone
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 6 to 8 cycles
- interventionNames
- Drug: Doxorubicin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: Dacarbazine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological review diagnosis available) * No prior treatment * Stage II B, III A and B, IV A and B * Normal hematopoietic function as measured by leucocytes equal to or greater than 3500/mm3, neutrophils equal to or greater than 1500/mm3, platelets equal to or greater than 100000/mm3 * Normal renal function (serum creatinine \< 1,5x ULN) and normal liver function (SGOT/SGPT equal to or lower than 2.5x ULN; bilirubin equal to or lower than 1.5x ULN) * No significant history or current evidence of cardiovascular disease, or major respiratory disease * No severe neurologic or psychiatric disease * No other malignancy except basal cell carcinoma of the skin and/or in situ cervical carcinoma of the uterus * Serological negativity for hepatitis B or C or HIV infection * ECOG performance status equal to or lower than 2 * Life expectancy of at least three months * Effective contraception in all patients and a negative pregnancy test for women of childbearing potential * Written informed consent and consent to a regular follow-up in the outpatient clinic Exclusion criteria: * Sever central nervous system or psychiatric disease * History or current evidence of clinically significant cardiac disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease or myocardial infarction or severe arrhythmias. Left ventricular ejection fraction \< 50% at rest by echocardiography or \< 55% by isotopic measurement * Serological positivity for HBV, HCV or HIV * History or current evidence of malignancy other than basal cell carcinoma of the skin, carcinoma in situ of the cervix * Lactating or pregnant women
References
Publications (1)
- DERIVEDViviani S, Zinzani PL, Rambaldi A, Brusamolino E, Levis A, Bonfante V, Vitolo U, Pulsoni A, Liberati AM, Specchia G, Valagussa P, Rossi A, Zaja F, Pogliani EM, Pregno P, Gotti M, Gallamini A, Rota Scalabrini D, Bonadonna G, Gianni AM; Michelangelo Foundation; Gruppo Italiano di Terapie Innovative nei Linfomi; Intergruppo Italiano Linfomi. ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned. N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340. PMID 21774708