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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival at 2 Years
Overall Survival at 5 Years
Progression-free Survival at 2 Years
+1 moreSecondary outcome measures
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 • NCT0200426282%
Vaccination site erythema
63%
Chills
56%
Vaccination site pain
56%
Vaccination site induration
54%
Pyrexia
54%
Vaccination site oedema
53%
Fatigue
52%
Vaccination site pruritus
45%
Nausea
34%
Vomiting
32%
Abdominal pain
27%
Constipation
27%
Vaccination site bruising
26%
Decreased appetite
20%
Anaemia
19%
Headache
19%
Hypotension
19%
Blood alkaline phosphatase increased
19%
Back pain
18%
Aspartate aminotransferase increased
16%
Oedema peripheral
14%
Disease progression
14%
Tachycardia
14%
Hyponatraemia
13%
Diarrhoea
13%
Alanine aminotransferase increased
13%
Thrombocytopenia
12%
Pruritus
11%
Weight decreased
11%
Hypertension
10%
Abdominal distension
10%
Insomnia
9%
Blood bilirubin increased
9%
Flatulence
9%
Ascites
9%
Erythema
9%
Abdominal pain upper
9%
Dehydration
9%
Hypoalbuminaemia
9%
Dyspnoea
9%
Pain
7%
Hypokalaemia
7%
Dizziness
7%
Myalgia
7%
Lymphocyte count decreased
6%
Gastrooesophageal reflux disease
6%
Hypoxia
6%
Pain in extremity
6%
Vaccination site vesicles
6%
Arthralgia
6%
Hypomagnesaemia
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Blood creatinine increased
6%
Pulmonary embolism
5%
Asthenia
5%
Night sweats
5%
Hypophosphataemia
5%
Blood albumin decreased
5%
Blood sodium decreased
5%
International normalised ratio increased
5%
Leukocytosis
5%
Deep vein thrombosis
5%
Confusional state
5%
Bile duct obstruction
4%
Abdominal Pain
3%
Sinus tachycardia
3%
Dry mouth
3%
Neuropathy peripheral
3%
Dry skin
3%
Urinary tract infection
3%
Upper respiratory tract infection
2%
Upper gastrointestinal haemorrhage
2%
Cough
2%
Cholangitis
2%
Cerebrovascular accident
2%
Anxiety
2%
Malignant pleural effusion
1%
Pneumonia
1%
Death
1%
Renal failure acute
1%
Failure to thrive
1%
Hallucination
1%
Haemorrhage
1%
Atrial fibrillation
1%
Hyperbilirubinaemia
1%
Hip fracture
1%
Myocardial infarction
1%
Gastrointestinal anastomotic complication
1%
Neutropenia
1%
Memory impairment
1%
Spinal cord compression
1%
Rash
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Gastritis
1%
Lower gastrointestinal haemorrhage
1%
Device dislocation
1%
Jaundice cholestatic
1%
Sepsis
1%
Herpes zoster
1%
Klebsiella sepsis
1%
Syncope
1%
Cerebral haemorrhage
1%
Transient ischaemic attack
1%
Superior vena cava syndrome
1%
Acute myocardial infarction
1%
Mental status changes
1%
Musculoskeletal chest pain
1%
Small intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: Cy/GVAX + CRS-207
Pooled Cohort: Chemotherapy
Pooled Cohort: CRS-207
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
394 Previous Clinical Trials
264,599 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
13,658 Previous Clinical Trials
40,924,070 Total Patients Enrolled
1,381 Trials studying Lymphoma
381,830 Patients Enrolled for Lymphoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared cyclophosphamide for general use?
"Cyclophosphamide received a score of 3 due to the presence of data from Phase 3 trials, which provides some support for efficacy as well as multiple rounds of data supporting safety."
Answered by AI
Are there still vacancies for willing participants in this research project?
"This study, which was posted on March 1st 2001 and last updated on September 23rd 2022, is no longer actively recruiting patients. However, there are 3258 other trials that are still looking for participants."
Answered by AI
For what purpose is cyclophosphamide most commonly indicated?
"While most commonly associated with the treatment of lung cancer, cyclophosphamide has also been shown to be an effective medication for treating thyroiditis, small cell lung cancer (sclc), and polyangium."
Answered by AI
Can you tell me if cyclophosphamide has been explored before in other research projects?
"cyclophosphamide was first studied in the year 1993 at National Institutes of Health Clinical Center, 9000 Rockville Pike. To date there have been 2415 completed studies. There are currently 1476 active trials, with many of these trials being performed out of Galesburg, Illinois."
Answered by AI
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