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
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.
--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
PMid: PMID35787017 | PMC number: PMID35787017
2018
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]
Other Clinical Trials
SWOG Clinical Trial Number
S2114
A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Research Committee(s)
Lymphoma
Activated
02/23/2023
Accrual
0%
Open
Phase
SWOG Clinical Trial Number
CTSU/ANHL1931
A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma.
Research Committee(s)
Lymphoma
Activated
06/07/2021
Open
Phase
SWOG Clinical Trial Number
S1918
A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
Research Committee(s)
Lymphoma
Activated
03/19/2021
Accrual
13%
Open
Phase