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Alkylating agents

Chemotherapy + Monoclonal Antibody Therapy for Non-Hodgkin's Lymphoma

Phase 3
Waitlist Available
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and over
Grade I-III disease
Must not have
No prior monoclonal antibodies for cancer
No prior radiotherapy for lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-5 years
Awards & highlights

Summary

This trial is comparing two different ways of treating non-Hodgkin's lymphoma with chemotherapy, using either one monoclonal antibody or two monoclonal antibodies.

Who is the study for?
This trial is for adults over 18 with newly diagnosed, untreated stage II-IV follicular non-Hodgkin's lymphoma that tests positive for CD20 antigen. Participants must have good performance status, adequate blood counts, no severe heart issues or CNS involvement by lymphoma. They cannot be pregnant/nursing and must use effective contraception.
What is being tested?
The study compares two monoclonal antibodies (rituximab and tositumomab) combined with chemotherapy drugs (cyclophosphamide, doxorubicin, prednisone, vincristine) in treating patients with non-Hodgkin's lymphoma. It aims to find out which antibody works better when paired with chemo.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs or antibodies used; damage to normal cells causing nausea, hair loss; increased risk of infections due to weakened immune system; potential heart problems from certain drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition is graded between I and III.
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I can take care of myself and am up and about more than half of my waking hours.
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I have a type of lymphoma that has not been treated and is in an advanced stage.
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My cancer cells test positive for CD20.
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My lymphoma has not spread to my brain or spinal cord.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never received monoclonal antibody treatment for cancer.
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I have not had radiation therapy for lymphoma.
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I have not had chemotherapy for lymphoma before.
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I have been diagnosed with congestive heart failure.
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I have severe heart artery problems.
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I have been diagnosed with cardiomyopathy.
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I have a serious irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival at 2 Years
Overall Survival at 5 Years
Progression-free Survival at 2 Years
+1 more
Secondary study objectives
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)

Side effects data

From 2016 Phase 2 trial • 303 Patients • NCT02004262
93%
Chills
67%
Pyrexia
51%
Nausea
44%
Fatigue
38%
Abdominal pain
37%
Vomiting
24%
Constipation
23%
Aspartate aminotransferase increased
22%
Headache
21%
Diarrhoea
21%
Anaemia
21%
Hypotension
18%
Decreased appetite
18%
Alanine aminotransferase increased
17%
Tachycardia
15%
Blood alkaline phosphatase increased
15%
Hypertension
15%
Back pain
13%
Myalgia
11%
Hypokalaemia
11%
Thrombocytopenia
11%
Dizziness
10%
Hypoalbuminaemia
8%
Pain
8%
Hyponatraemia
8%
Pain in extremity
8%
Dyspnoea
8%
Blood albumin decreased
7%
Dehydration
7%
Oedema peripheral
7%
Hypomagnesaemia
7%
Weight decreased
7%
Sinus tachycardia
6%
Disease progression
6%
Dry mouth
6%
Flatulence
6%
Arthralgia
6%
Pruritus
6%
Cough
6%
Insomnia
6%
Anxiety
5%
Abdominal Pain
5%
Abdominal pain upper
5%
Abdominal distension
5%
Hypophosphataemia
5%
Lymphocyte count decreased
5%
Blood creatinine increased
5%
Blood sodium decreased
5%
Rash
5%
Night sweats
5%
Confusional state
3%
Ascites
3%
Asthenia
3%
Hyperglycaemia
3%
Blood bilirubin increased
3%
Pulmonary embolism
3%
Hypoxia
3%
Bile duct obstruction
3%
Urinary tract infection
2%
Gastrointestinal haemorrhage
2%
Small intestinal obstruction
2%
Gastrooesophageal reflux disease
2%
Leukocytosis
2%
Obstruction gastric
1%
Blood glucose decreased
1%
Colitis
1%
Oesophagitis
1%
Cholangitis
1%
Death
1%
Pneumonia
1%
Portal vein thrombosis
1%
Bacteraemia
1%
Lung infection
1%
Influenza
1%
Cerebrovascular accident
1%
Hypercalcaemia
1%
Orthostatic hypotension
1%
Venous thrombosis
1%
Venous thrombosis limb
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Fall
1%
Oliguria
1%
Mental status changes
1%
Delirium
1%
Hyperkalaemia
1%
Neutropenia
1%
Deep vein thrombosis
1%
Neuropathy peripheral
1%
Erythema
1%
Encephalopathy
1%
Respiratory failure
1%
Pneumonia klebsiella
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: CRS-207
Pooled Cohort: Cy/GVAX + CRS-207
Pooled Cohort: Chemotherapy

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (CHOP + tositumomab)Experimental Treatment5 Interventions
Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.
Group II: Arm II (CHOP + rituximab)Experimental Treatment5 Interventions
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141.
Group III: Arm I (CHOP only)Active Control4 Interventions
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Prednisone
FDA approved
Vincristine
FDA approved
tositumomab
2005
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
396 Previous Clinical Trials
264,881 Total Patients Enrolled
37 Trials studying Lymphoma
6,489 Patients Enrolled for Lymphoma
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
117,417 Total Patients Enrolled
7 Trials studying Lymphoma
2,123 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,266 Total Patients Enrolled
1,402 Trials studying Lymphoma
382,394 Patients Enrolled for Lymphoma
~23 spots leftby Oct 2025
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