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

Other Clinical Trials

SWOG Clinical Trial Number
S2308

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

Research Committee(s)
Lymphoma
Activated
08/01/2024
Accrual
1%
Open
Phase
SWOG Clinical Trial Number
CTSU/AHOD2131