Phase 3
Completed N=1,334
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT01712490 ↗Enrolled (actual)
1,334
Serious AEs
35.0%
Results posted
Nov 2018
Primary outcomePrimary: Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) — NA; NA months — p=0.035
◆ Published Evidence
Highly cited
330citations · ~83 / year
Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma.
Summary
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)
Linked Publications (5)
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Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma.
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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.
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Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study.
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Brentuximab vedotin with chemotherapy in adolescents and young adults with stage III or IV classical Hodgkin lymphoma in ECHELON-1.
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Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) |
NA; NA | 0.035 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.199 |
| SECONDARY Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF |
73; 70 | — |
| SECONDARY Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |
653; 646; 284; 178 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Values |
662; 658 | — |
| SECONDARY Event-free Survival (EFS) Per IRF |
NA; NA | — |
| SECONDARY Disease-free Survival (DFS) Per IRF |
NA; NA | — |
| SECONDARY Overall Response Rate (ORR) Per IRF |
86; 83 | — |
| SECONDARY Duration of Response (DOR) Per IRF |
NA; NA | — |
| SECONDARY Duration of Complete Remission (DOCR) Per IRF |
NA; NA | — |
| SECONDARY Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy |
8; 13 | — |
| SECONDARY Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy |
73; 71 | — |
| SECONDARY Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2 |
89; 86 | — |
| SECONDARY A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb) |
22.9; 23.6; 22.6; 26.4 | — |
| SECONDARY A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE) |
3.20; 1.36 | — |
| SECONDARY A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb |
47.4; 93.0 | — |
| SECONDARY A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE |
25.3 | — |
| SECONDARY A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin |
109; 12 | — |
| SECONDARY Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT |
78.15; 76.68; 79.85; 79.91; 2.68; 8.58 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve participants with Ann Arbor Stage III or IV HL.
- Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
- Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
Exclusion Criteria
- Nodular lymphocyte predominant Hodgkin lymphoma.
- Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
- Sensory or motor peripheral neuropathy.
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
- Known human immunodeficiency virus (HIV) positive.
- 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.
Data sourced from ClinicalTrials.gov (NCT01712490) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.