A randomized Phase III trial of Brentuximab vedotin (Bv) for de novo High-Risk Classical Hodgkin Lymphoma (cHL) in children and adolescents - Study Design and Incorporation of secondary endpoints in Children’s Oncology Group (COG) AHOD1331

2020 ◽  
Author(s):  
SM Castellino ◽  
SK Parsons ◽  
Q Pei ◽  
K McCarten ◽  
S Kessel ◽  
...  
Keyword(s):  
High Risk ◽  
Children And Adolescents ◽  
Hodgkin Lymphoma ◽  
De Novo ◽  
Brentuximab Vedotin ◽  
Phase Iii ◽  
Classical Hodgkin Lymphoma ◽  
Oncology Group ◽  
Phase Iii Trial ◽  
Secondary Endpoints

scholarly journals Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study

Haematologica ◽  
2021 ◽  
Author(s):  
Andrew M. Evens ◽  
Joseph M. Connors ◽  
Anas Younes ◽  
Stephen M. Ansell ◽  
Won Seog Kim ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Older Patients ◽  
Progression Free Survival ◽  
Brentuximab Vedotin ◽  
Phase Iii ◽  
Classical Hodgkin Lymphoma ◽  
Free Survival ◽  
Younger Patients ◽  
Independent Review ◽  
Large Phase

Effective and tolerable treatments are needed for older patients with classical Hodgkin lymphoma (cHL). We report results for older patients with cHL treated in the large phase III ECHELON-1 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Modified progression-free survival (PFS) per independent review facility (IRF) for older versus younger patients (aged ≥60 versus

Approach and Feasibility of Patient-Reported Outcomes (PROs) in a Phase III Clinical Trial for Advanced Stage Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3583-3583 ◽  
Author(s):  
Tara O Henderson ◽  
Sharon M Castellino ◽  
Frank G Keller ◽  
Kara M. Kelly ◽  
Rachael Curtis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Children And Adolescents ◽  
Hodgkin Lymphoma ◽  
Healthcare Utilization ◽  
Patient Reported Outcomes ◽  
Parent Report ◽  
Phase Iii ◽  
Classical Hodgkin Lymphoma ◽  
Patient Reported

Abstract Introduction: Given the high cure rates in classical Hodgkin lymphoma (cHL) with conventional therapy, careful consideration of the economics of newer agents should be considered. We describe the feasibility of embedding Patient-Reported Outcomes (PROs) for chemotherapy-induced peripheral neuropathy (CIPN) and cost effectiveness (CEA) in a randomized, multi-institutional Phase III study [NCT02166463; Children's Oncology Group (COG) AHOD1331], evaluating the efficacy of the novel agent, Brentuximab vedotin, for advanced cHL in children and adolescents. Methods: Recruitment for PROs of interest is targeted for 250 of the planned 600 trial participants. Participation in the trial includes prospective collection of patient- and parent proxy-reported outcomes. CIPN is evaluated with the 11-item FACT-GOG-NTX and paired with the 9-item CHRIs-Global to serially evaluate health-related quality of life (HRQL) consequences of CIPN from initial diagnosis to 12 months off therapy. For CEA, US-based participants are queried from diagnosis through 36 months off therapy with the 4-item Stanford Healthcare Utilization Questionnaire (parent-report), the Health Utilities Index (HUI) 2/3, and the 23-item Caregiver Work Limitations Questionnaire (parent-report) as a measure of productivity loss. A study-designated research assistant is charged with contacting site personnel at study entry and at each scheduled assessment. All data are uploaded into a web-based relational database for future analysis. Units of healthcare utilization from the Stanford Healthcare Utilization measure and adverse events (AE) requiring hospitalization will be monetized with unit costs from US-based administrative databases, including the US National Inpatient Sample (NIS) and Kids' Inpatient Database (KID), Massachusetts All-Payer Claims Database (APCD) and Medicare, based on site of care and diagnostic and/or procedure codes. Data on severe AE from the two predecessor trials (COG AHOD 0031 and AHOD 0831) will be monetized as a training exercise. Total costs will be calculated by study arm and will include monetization of significant adverse events and health care utilization and will be expressed as cost per quality-adjusted life year derived from the HUI. Results: The clinical trial, activated in March 2015, has enrolled 161 participants; accrual is ongoing at 172 participating institutions. 156 participants (>95%) have completed the baseline CIPN and CEA measures. Among participants who have completed the baseline CIPN and CEA assessments, 90% have completed subsequent measures. Monetization of significant adverse events and utilization is in progress. Conclusion: We demonstrate a feasible approach evidenced by high completion rates of assessments for prospective evaluation of CIPN, HRQL, and healthcare utilization in a multi-institutional trial of children with advanced HL. Our experience serves as a proof of principle to cooperative groups regarding the resources and the feasibility of incorporating necessary PRO and health utilization outcomes into Phase III clinical trials as a component of cancer care delivery research. Disclosures Henderson: Seattle Genetics: Research Funding.

scholarly journals Randomized Phase III Trial of ABVD Versus Stanford V With or Without Radiation Therapy in Locally Extensive and Advanced-Stage Hodgkin Lymphoma: An Intergroup Study Coordinated by the Eastern Cooperative Oncology Group (E2496)

2013 ◽  
Vol 31 (6) ◽  
pp. 684-691 ◽  
Author(s):  
Leo I. Gordon ◽  
Fangxin Hong ◽  
Richard I. Fisher ◽  
Nancy L. Bartlett ◽  
Joseph M. Connors ◽  
...  
Keyword(s):  
Complete Remission ◽  
Hodgkin Lymphoma ◽  
Eastern Cooperative Oncology Group ◽  
Standard Of Care ◽  
Phase Iii ◽  
Random Assignment ◽  
Oncology Group ◽  
Phase Iii Trial ◽  
Free Survival ◽  
End Point

Purpose Although ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) has been established as the standard of care in patients with advanced Hodgkin lymphoma, newer regimens have been investigated, which have appeared superior in early phase II studies. Our aim was to determine if failure-free survival was superior in patients treated with the Stanford V regimen compared with ABVD. Patients and Methods The Eastern Cooperative Oncology Group, along with the Cancer and Leukemia Group B, the Southwest Oncology Group, and the Canadian NCIC Clinical Trials Group, conducted this randomized phase III trial in patients with advanced Hodgkin lymphoma. Stratification factors included extent of disease (localized v extensive) and International Prognostic Factors Project Score (0 to 2 v 3 to 7). The primary end point was failure-free survival (FFS), defined as the time from random assignment to progression, relapse, or death, whichever occurred first. Overall survival, a secondary end point, was measured from random assignment to death as a result of any cause. This design provided 87% power to detect a 33% reduction in FFS hazard rate, or a difference in 5-year FFS of 64% versus 74% at two-sided .05 significance level. Results There was no significant difference in the overall response rate between the two arms, with complete remission and clinical complete remission rates of 73% for ABVD and 69% for Stanford V. At a median follow-up of 6.4 years, there was no difference in FFS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32). Conclusion ABVD remains the standard of care for patients with advanced Hodgkin lymphoma.

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