SWOG clinical trial number
S0816

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Phase II Stage III-IV Hodgkin's: FDG-PET Imaging Study
Activated
07/01/2009
Closed
12/01/2012
Participants
NCORP, Members, Medical Oncologists, Pathologists, ECOG, CALGB, CTSU, Affiliates

Research committees

Lymphoma

Treatment

Cyclophosphamide Prednisone Vincristine Bleomycin Doxorubicin DTIC Etoposide Vinblastine Sulfate Procarbazine ABVD BEACOPP

Eligibility Criteria Expand/Collapse

Pts must have untreated Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich or lymphocyte depleted. Nodular lymphocyte predominant Hodgkin is not eligible. Adequate sections and paraffin block from original diagnostic specimen must be available for central review submission. Pts must be offered participation in correlative science. Pts must be age 18-60, inclusive. Pts must have bidimensionally measurable disease. Pts must have unilateral or bilateral bm biopsy. Pts must have CT scan of chest/abdomen and pelvis, and baseline FDG-PET scan. Pts must not have prior chemotherapy, radiation or antibody therapy for lymphoma. Pts must have Zubrod PS of 0-2. Serum erythrocyte sedimentation rate (ESR), LDH, hemoglobin, albumin, WBC and lymphocytes must be measured. Pts with history of hypertension or cardiac symptoms must have MUGA or ECHO with no significant abnormalities and cardiac EF >/= 45%. Pts must not be sero-positive for Hep B or Hep C. Pts who are immune to Hep B are eligible. HIV status must be known prior to reg. HIV+ pts must not have multi-drug resistant HIV, CD4 counts <350/mcl or other concurrent AIDS-defining conditions. Pts must not have significant lung disease with abnormal LFTs (DLCO >25% below predicted after correction for hemoglobin) unless attributable to lymphoma. Pts must not require continuous supplemental oxygen. Pts must not have prior solid organ transplant. Pts must not have prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer (currently in complete remission) or any other cancer from which the pt has been disease-free for 5 years. Pts must not be pregnant or nursing. Women/men of reproductive potential must agree to use effective contraception during study and for at least 6 months after completion of therapy.

Publication Information Expand/Collapse

2019

Serum levels of TARC, MDC, IL10 and soluble CD163 in the setting of risk adapted therapy for Hodgkin lymphoma: SWOG S0816 correlative study

E Hsi;H Li;A Nixon;H Schoder;N Bartlett;M Leblanc;S Smith;B Kahl;J Leonard;A Evens;L Rimsza;JW Friedberg Blood Apr 18;133(16):1762-1765; Feb 5. pii: blood-2018-08-870915. doi: 10.1182/blood-2018-08-870915. [Epub ahead of print]

PMid: PMID30723079 | PMC number: PMC6473498

Long-term Follow-up of SWOG S0816: Response-Adapted Therapy for Stage III/IV Hodgkin Lymphoma Demonstrates Limitations of PET-adapted Approach

DM Stephens;H Li;H Schoder;DJ Straus;CH Moskowitz;M Leblanc;L Rimsza;NL Bartlett;AM Evens;AS Lacasce;PM Barr;MV Knopp;ED Hsi;JP Leonard;B Kahl;SM Smith;JW Friedberg Blood, Jul 22. pii: blood.2019000719. doi: 10.1182/blood.2019000719. [Epub ahead of print]

PMid: PMID31331918

2018

Potential impact of consolidation radiation therapy for advanced Hodgkin Lymphoma: a secondary modeling analysis of SWOG S0816

C Ha;H Li;H Schoder;C Pinnix;E Brem;N Bartlett;A Evens;E Hsi;L Rimsza;J Leonard;B Kahl;M Leblanc;S Smith;L Constine;JW Friedberg International Symposium on Hodgkin Lymphoma (October 27-29, 2018, Cologne, Germany), abst #T019 (0026), oral

Long-term Follow-up of SWOG S0816: Response-Adapted Therapy for Stage III/IV Hodgkin Lymphoma Demonstrates Limitations of PET-adapted Approach

D Stephens;H Li;H Schoder;D Straus;C Moskowitz;M Leblanc;L Rimsza;N Bartlett;A Evens;A Lacasce;P Barr;M Knopp;E Hsi;J Leonard;B Kahl;S Smith;JW Friedberg Blood 132:929; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), oral

Potential impact of consolidation radiation therapy for advanced Hodgkin Lymphoma: a secondary modeling of SWOG S0816 with receiver operating characteristic analysis

C Ha;H Li;H Schoder;C Pinnix;E Brem;N Bartlett;A Evens;E Hsi;L Rimsza;J Leonard;BS Kahl;M Leblanc;S Smith;L Constine;JW Friedberg Blood 132:2927; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster

2017

The 23-gene gene expression-based assay does not predict interim PET scan results after ABVD in advanced stage classical Hodgkin lymphoma in the US Intergroup S0816 trial

DW Scott;H Li;Y Harvey;F Chun Chan;A Mottok;M Boyle;AM Evens;H Schoder;DJ Strauss;N Bartlett;J Sweetenham;P Barr;M Fanale;ED Hsi;JR Cook;B Kahl;JP Leonard;JW Friedberg;M LeBlanc;C Steidl;R Gascoyne;L Rimsza;OW Press International Conference on Malignant Lymphoma (June 14-17, 2017, Lugano, Switzerland), oral

Serum levels of TARC, MDC, IL10 and soluble CD163 in the setting of risk adapted therapy for Hodgkin lymphoma: SWOG S0816 correlative study

E Hsi;H Li;AB Nixon;AM Evens;H Schoder;D Straus;N Bartlett;J Sweetenham;PM Barr;MA Fanale;JR Cook;BS Kahl;JP Leonard;S Smith;M LeBlanc;LM Rimsza;JW Friedberg;OW Press Blood 130:4033; American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), poster

2016

A US intergroup trial of response-adapted therapy of stage III–IV hodgkin lymphoma using early interim FDG–PET imaging (SWOG S0816)

O Press;H Li;H Schoder;CH Moskowitz;DJ Strauss;M LeBlanc;L Rimsza;NL Bartlett;A Evens;E Mittra;AS LaCasce;JW Sweetenham;P Barr;M Fanale;M Knopp;A Noy;E Hsi;J Cook;M Lechowicz;R Gascoyne;JP Leonard;B Kahl;B Cheson;RI Fisher;JW Friedberg Journal of Clinical Oncology Jun 10;34(17):2020-2027; 2016 Apr 11 [Epub ahead of print]

PMid: PMID27069074 | PMC number: PMC4966513

Feasibility of interim positron emission tomography (PET)-adapted therapy in HIV-positive patients with advanced Hodgkin Lymphoma (HL): a sub-analysis of SWOG S0816 phase 2 trial

A Danilov;H Li;O Press;I Shapira;L Swinnen;A Noy;E Reid;S Smith;J Friedberg Leukemia & Lymphoma Feb;58(2):461-465; 2016 Jul 7:1-5. [Epub ahead of print] [print in 2017]

PMid: PMID27386786 | PMC number: PMC5130311

Reply to H.J.A. Adams et al and E.A. Hawkes et al [correspondence re S0816]

O Press;J Friedberg Journal of Clinical Oncology; DOI: 10.1200/JCO.2016.69.7979; online before print October 28, 2016

PMid: PMID27069074 | PMC number: n/a - correspondence

Long-term follow-up of SWOG S0816: Response-adapted therapy of advanced stage Hodgkin lymphoma using early interim FDG-PET imaging

JW Friedberg;H Li;H Schoder;D Strauss;CH Moskowitz;M Leblanc;L Rimsza;N Bartlett;A Evens;E Mittra;AS LaCasce;J Sweetenham;P Barr;M Fanale;M Knopp;A Noy;E Hsi;J Cook;M Lechowicz;R Gascoyne;JP Leonard;BS Kahl;B Cheson;R Fisher;OW Press Haematologica Oct 2016 101:19 (abst T003); International Symposium on Hodgkin Lymphoma (Oct 22-25, 2016, Cologne, Germany), oral

Hodgkin lymphoma: Current status and clinical trial recommendations

CS Diefenbach;JM Connors;JW Friedberg;JP Leonard;BS Kahl;RF Little;L Baizer;AM Evens;RT Hoppe;KM Kelly;DO Persky;A Younes;L Kostakaglu;NL Bartlett Journal of the National Cancer Institute, Dec 31;109(4). pii: djw249

PMid: PMID28040700 | PMC number: PMC n/a - Review

2015

Feasibility of interim PET-adapted therapy in HIV-positive patients with advanced Hodgkin Lymphoma (HL) – sub-analysis of SWOG S0816 phase 2 trial

A Danilov;H Li;O Press;I Shapira;L Swinnen;A Noy;E Reid;S Smith;J Friedberg Blood 126(23):1498; American Society of Hematology Annual Meeting (Dec 5-8, Orlando, FL), poster;

2013

A phase II trial of response-adapted therapy of stage III-IV hodgkin lymphoma using early interim FDG-PET imaging: SWOG S0816

O Press;M LeBlanc;L Rimsza;H Schoder;J Friedberg;H Li;N Bartlett;A LaCasce;J Sweetenham;A Evens;D Strauss;M Knopp;A Noy;R Gascoyne;B Cheson;B Kahl;TP Miller;RI Fisher Hematological Oncology 31(suppl.1):abstr. #24, p. 137; Intl Conference on Malignant Lymphoma (June 19-22, 2013, Lugano, Switzerland), oral presentation;