Trial Outcomes & Findings for S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma (NCT NCT00070018)

Last Updated: 2022-01-11

Results Overview

Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter

Results posted on

2022-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	CHOP + RT + Zevalin Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Overall Study STARTED	46
Overall Study Eligible	46
Overall Study Eligible and Began Protocol Therapy	46
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CHOP + RT + Zevalin Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHOP + RT + Zevalin n=46 Participants Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Age, Continuous	61.2 years n=99 Participants
Sex: Female, Male Female	16 Participants n=99 Participants
Sex: Female, Male Male	30 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	42 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter

Outcome measures

Outcome measures
Measure	CHOP + RT + Zevalin n=46 Participants Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Progression-free Survival	89 percentage of participants Interval 76.0 to 95.0

Adverse Events

CHOP + RT + Zevalin

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CHOP + RT + Zevalin n=46 participants at risk Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Blood and lymphatic system disorders Febrile neutropenia	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Blood and lymphatic system disorders Hemoglobin	60.9% 28/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Constipation	34.8% 16/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Diarrhea	19.6% 9/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	21.7% 10/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Dysphagia (difficulty swallowing)	13.0% 6/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Esophagitis	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Heartburn/dyspepsia	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	17.4% 8/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Nausea	45.7% 21/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Pain - Oral cavity	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Gastrointestinal disorders Vomiting	23.9% 11/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
General disorders Edema: limb	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
General disorders Fatigue (asthenia, lethargy, malaise)	71.7% 33/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Injury, poisoning and procedural complications Rash: dermatitis associated with radiation - Radiation	34.8% 16/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	13.0% 6/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	17.4% 8/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Bilirubin (hyperbilirubinemia)	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Creatinine	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Leukocytes (total WBC)	63.0% 29/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Lymphopenia	41.3% 19/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Neutrophils/granulocytes (ANC/AGC)	58.7% 27/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Platelets	54.3% 25/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Investigations Weight loss	17.4% 8/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Metabolism and nutrition disorders Anorexia	15.2% 7/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Metabolism and nutrition disorders Dehydration	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	26.1% 12/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Musculoskeletal and connective tissue disorders Pain - Bone	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Musculoskeletal and connective tissue disorders Pain - Muscle	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Nervous system disorders Dizziness	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Nervous system disorders Neuropathy: sensory	30.4% 14/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Nervous system disorders Pain - Head/headache	13.0% 6/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Nervous system disorders Taste alteration (dysgeusia)	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Psychiatric disorders Mood alteration - depression	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Respiratory, thoracic and mediastinal disorders Cough	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam) - Pharynx	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic) - Pharynx	10.9% 5/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Skin and subcutaneous tissue disorders Dermatology/Skin-Other (Specify)	8.7% 4/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	52.2% 24/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Skin and subcutaneous tissue disorders Rash/desquamation	17.4% 8/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Vascular disorders Hypotension	6.5% 3/46 • After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place