Clinical trial · Interventional
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
NCT01712490CI-TRIAL-00104259completedPhase 3Results postedClinicalTrials.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)
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin | Drug | Bleomycin | ALIAS |
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A + AVD
- description
- A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
- interventionNames
- Drug: brentuximab vedotin
- Drug: doxorubicin
- Drug: vinblastine
- Drug: dacarbazine
- type
- ACTIVE_COMPARATOR
- label
- ABVD
- description
- ABVD consists of doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
- interventionNames
- Drug: doxorubicin
- Drug: bleomycin
- Drug: vinblastine
- Drug: dacarbazine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Treatment-naïve participants with Ann Arbor Stage III or IV HL. 2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification. 3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2. 4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma. Exclusion Criteria: 1. Nodular lymphocyte predominant Hodgkin lymphoma. 2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML). 3. Sensory or motor peripheral neuropathy. 4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose. 5. Known human immunodeficiency virus (HIV) positive. 6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
References
Publications (9)
- DERIVEDKreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3. PMID 40135712
- DERIVEDCrosswell HE, LaCasce AS, Bartlett NL, Straus DJ, Savage KJ, Zinzani PL, Collins GP, Fanale M, Fenton K, Dong C, Miao H, Grigg AP. Brentuximab vedotin with chemotherapy in adolescents and young adults with stage III or IV classical Hodgkin lymphoma in ECHELON-1. Haematologica. 2024 Mar 1;109(3):982-987. doi: 10.3324/haematol.2023.283303. No abstract available. PMID 37794803
- DERIVEDAnsell SM, Radford J, Connors JM, Dlugosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM, Smolewski P, Savage KJ, Bartlett NL, Eom HS, Abramson JS, Dong C, Campana F, Fenton K, Puhlmann M, Straus DJ; ECHELON-1 Study Group. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2022 Jul 28;387(4):310-320. doi: 10.1056/NEJMoa2206125. Epub 2022 Jul 13. PMID 35830649
- DERIVEDEvens AM, Connors JM, Younes A, Ansell SM, Kim WS, Radford J, Feldman T, Tuscano J, Savage KJ, Oki Y, Grigg A, Pocock C, Dlugosz-Danecka M, Fenton K, Forero-Torres A, Liu R, Jolin H, Gautam A, Gallamini A. Older patients (aged >/=60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. Haematologica. 2022 May 1;107(5):1086-1094. doi: 10.3324/haematol.2021.278438. PMID 34162178
- DERIVEDStraus DJ, Dlugosz-Danecka M, Connors JM, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2.