Phase 3
N=1,334
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01712490 ↗Enrolled (actual)
1,334
Serious AEs
35.0%
Results posted
Nov 2018
Primary outcome: Primary: Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) — NA; NA months — p=0.035
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- brentuximab vedotin (Drug); doxorubicin (Drug); bleomycin (Drug); vinblastine (Drug); dacarbazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2017
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 | — |
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)
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). 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.