SWOG clinical trial number
S0801

A Phase II Study of Iodine-131 Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma

Closed
Phase
Accrual
100%
Abbreviated Title
NON-HODGKIN: Bexxar + CHOP-Rituximab for Advanced Follicular NHL
Activated
04/01/2009
Closed
12/15/2010
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Lymphoma

Treatment

Cyclophosphamide Prednisone Vincristine Doxorubicin Rituximab Tositumomab CHOP

Eligibility Criteria Expand/Collapse

--Previously untreated Stage III, IV, or bulky Stage II follicular B-cell NHL, which is positive for CD20.
--Must be age 18 or older.
--Must have a performance status of 0, 1, or 2.
--Must have bidimensionally measurable disease.
--Adequate sections from the original biopsy specimen must be available for pathology review.
--Must have a unilateral or bilateral bone marrow asp/biopsy w/in 42 days prior to registration unless a positive bone marrow asp/biopsy was done within 6 months prior to registration.
--Must have a diagnostic CT scan of chest and abdomen/pelvis w/in 28 days prior to registration. PET/CT scan is allowed if CT is of diagnostic quality and contrast enhanced.
-Must have a cardiac ejection fraction >/= 45% by MUGA or ECHO w/ no significant abnormalities w/in 42 days prior to registration.
--Must not have prior malignancy except adequately treated basal cel or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which patient is in CR, or any other cancer from which patient is disease free for >/= 5 yrs.
--No prior chemotherapy, RT, or antibody therapy for lymphoma.
--Must not be pregnant or nursing.
--Must not be HIV positive or have a history of solid organ transplantation. Patients at high risk of Hepatitis B virus (HBV) infection are eligible.
--Must not be requiring continuous supplemental oxygen therapy.
--Must not have clinical evidence of CNS involvement by lymphoma.

Publication Information Expand/Collapse

2023

Relevance of bone marrow biopsies for response assessment in U.S. National Cancer Institute National Clinical Trials Network follicular lymphoma clinical trials

S Rutherford;J Yin;L Pederson;G Perez Burbano;P LaPlant;M Shadman;H Li;M LeBlanc;V Kenkre;F Hong;K Blum;T Dockter;P Martin;S Jung;B Grant;C Rosenbaum;C Ujjani;P Barr;J Unger;B Cheson;N Bartlett;B Kahl;JW Friedberg;S Mandrekar;J Leonard Journal of Clinical Oncology 10;41(2):336-342

PMid: PMID35787017 | PMC number: PMC9839232

2020

Relevance of bone marrow biopsies for response assessment in NCTN follicular lymphoma clinical trials

S Rutherford;J Yin;L Pederson;B LaPlant;M Shadman;H Li;M LeBlanc;K Blum;T Dockter;P Martin;S Jung;B Grant;C Rosenbaum;C Ujjani;P Barr;J Unger;N Bartlett;JW Friedberg;J Leonard J Clin Oncol 38: 2020 (suppl; abstr 8038); American Society of Clinical Oncology 2020 Annual Meeting, poster

2018

Phase 2 study of RCHOP, radioimmunotherapy and maintenance rituximab in untreated follicular lymphoma: SWOG S0801

P Barr;H Li;WR Burack;M Leblanc;S Smith;AK Gopal;JD Floyd;D Persky;O Press;RI Fisher;JW Friedberg Lancet Haematology Mar;5(3):e102-e108; 2018 Jan 25 [Epub ahead of print]

PMid: PMID29396094 | PMC number: PMC6501182

2016

Sequential RCHOP, radioimmunotherapy and rituximab maintenance improves early outcomes in advanced stage follicular lymphoma: 5 year outcomes from SWOG 0801 [http://www.bloodjournal.org/content/128/22/614]

P Barr;H Li;WR Burack;M Leblanc;S Smith;AK Gopal;JD Floyd;D Persky;O Press;RI Fisher;JW Friedberg Blood 128:614; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral presentation