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Monoclonal Antibodies
rituximab for Lymphoma
Phase 3
Waitlist Available
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed (by restaging ct scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as day 1, until rituximab failure observed or july 17, 2013, whichever occurred first.
Awards & highlights
Study Summary
This trial is studying two different schedules of rituximab to see which is more effective in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed (by restaging ct scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as day 1, until rituximab failure observed or july 17, 2013, whichever occurred first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed (by restaging ct scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as day 1, until rituximab failure observed or july 17, 2013, whichever occurred first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Rituximab Failure (TTRF)
Secondary outcome measures
Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization
Time to First Cytotoxic Therapy (TTFC)
Side effects data
From 2011 Phase 3 trial • 224 Patients • NCT0112654120%
Bronchitis
17%
Asthenia
17%
Cough
15%
Back pain
14%
Urinary tract infection
12%
Gastroenteritis
12%
Rheumatoid arthritis
11%
Nausea
11%
Headache
11%
Nasopharyngitis
11%
Hypercholesterolaemia
8%
Abdominal pain upper
8%
Conjunctivitis
8%
Vertigo
6%
Vomiting
6%
Pharyngitis
6%
Tonsillitis
6%
Sinusitis
6%
Hypertension
6%
Rash
5%
Hot flush
5%
Abdominal pain
5%
Pyrexia
5%
Dysphagia
5%
Rhinitis
5%
Influenza
5%
Sciatica
5%
Rhinitis allergic
3%
Limb injury
3%
Upper respiratory tract infection
3%
Fungal skin infection
3%
Osteoarthritis
3%
Arthralgia
3%
Bronchopneumonia
3%
Musculoskeletal pain
3%
Arthritis
3%
Feeling hot
3%
Productive cough
3%
Larynx irritation
3%
Lipoma
3%
Dry eye
3%
Gingivitis
3%
Tracheitis
3%
Fungal infection
3%
Diarrhoea
3%
Depression
3%
Sleep disorder
3%
Constipation
3%
Neck pain
3%
Chronic obstructive pulmonary disease
3%
Erythema
3%
Eczema
3%
Urticaria
3%
Night sweats
3%
Transaminases increased
3%
Weight increased
2%
Rheumatoid nodule
2%
Bursitis
2%
Tendonitis
2%
Oedema
2%
Hypertriglyceridaemia
2%
Viral upper respiratory tract infection
2%
Calculus bladder
2%
Spinal compression fracture
2%
Oral herpes
2%
Pyelonephritis acute
2%
Restless legs syndrome
2%
Bowen's disease
2%
Pain
2%
Angioedema
2%
Rotator cuff syndrome
2%
Oedema peripheral
2%
Vulvovaginal mycotic infection
2%
Prostate infection
2%
Cellulitis
2%
Chronic sinusitis
2%
Abdominal wall abscess
2%
Pertussis
2%
Viral infection
2%
Arthropathy
2%
Gastroenteritis viral
2%
Toe deformity
2%
Myalgia
2%
Bone pain
2%
Monarthritis
2%
Chest discomfort
2%
Osteopenia
2%
Synovitis
2%
Cervical root pain
2%
Gastric ulcer
2%
Pharyngeal oedema
2%
Chest injury
2%
Cervicobrachial syndrome
2%
Pharyngeal erythema
2%
Memory impairment
2%
Obesity
2%
Chalazion
2%
Dyspnoea
2%
Stress fracture
2%
Humerus fracture
2%
Tendon rupture
2%
Traumatic haematoma
2%
Wrist fracture
2%
Ankle fracture
2%
Rib fracture
2%
Procedural pain
2%
Eczema nummular
2%
Hyperglycaemia
2%
Anaemia
2%
Keratoconjunctivitis sicca
2%
Visual acuity reduced
2%
Thrombocythaemia
2%
Lymphadenopathy
2%
Iron deficiency anaemia
2%
Hepatomegaly
2%
Cholestasis
2%
Onychomycosis
2%
Fatigue
2%
Blood lactate dehydrogenase increased
2%
Blood phosphorus decreased
2%
Ocular hypertension
2%
Retinopathy hypertensive
2%
Urinary retention
2%
Acute sinusitis
2%
Escherichia urinary tract infection
2%
Gastrointestinal disorder
2%
Aphthous stomatitis
2%
Toothache
2%
Venous insufficiency
2%
Anxiety
2%
Breast cancer
2%
Uterine leiomyoma
2%
Vasculitis
2%
Intervertebral disc disorder
2%
Blood thyroid stimulating hormone decreased
2%
Uveitis
2%
Cataract
2%
Bursitis infective
2%
Perianal abscess
2%
Hypertensive crisis
2%
Goitre
2%
Sinobronchitis
2%
Ear infection
2%
Otitis externa
2%
Hypokalaemia
2%
Osteoporosis
2%
Paraesthesia
2%
Throat irritation
2%
Pharyngolaryngeal pain
2%
Asthma
2%
Dysphonia
2%
Dyspnoea exertional
2%
Sleep apnoea syndrome
2%
Epistaxis
2%
Pruritus
2%
Alopecia
2%
Hyperhidrosis
2%
Photosensitivity reaction
2%
Skin exfoliation
2%
Joint injury
2%
Animal bite
2%
Foot fracture
2%
Diabetes mellitus
2%
Phlebitis
2%
Eosinophil count increased
2%
Ventricular extrasystoles
2%
Bundle branch block left
2%
Palpitations
2%
Deoxyribonucleic acid (DNA) antibody positive
2%
Electrocardiogram repolarisation abnormality
2%
Lymphocyte count decreased
2%
Neutrophil count increased
2%
Eye irritation
2%
Lymphopenia
2%
Neutropenia
2%
Tinnitus
2%
Vertigo positional
2%
Basosquamous carcinoma
2%
Renal colic
2%
Renal impairment
2%
Cataract operation
2%
Skin neoplasm excision
2%
Allergy to chemicals
2%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Retreatment Arm A: Rituximab 1000 mg
Nonrandomized: Rituximab 1000 mg
Randomized Retreatment Arm B: Rituximab 1000 mg x 2
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Rituximab ScheduledExperimental Treatment1 Intervention
Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
Group II: Arm A: Rituximab RetreatmentActive Control1 Intervention
Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rituximab
2000
Completed Phase 3
~2760
Find a Location
Who is running the clinical trial?
Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
150,285 Total Patients Enrolled
25 Trials studying Lymphoma
7,126 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,122 Total Patients Enrolled
1,381 Trials studying Lymphoma
381,855 Patients Enrolled for Lymphoma
Brad S. Kahl, MDStudy ChairUniversity of Wisconsin, Madison
2 Previous Clinical Trials
818 Total Patients Enrolled
2 Trials studying Lymphoma
818 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.
What are the short-term and long-term risks associated with rituximab?
"There is both anecdotal and clinical evidence to support the safety of rituximab, giving it a score of 3."
Answered by AI
Is this the first time rituximab is being tested in a clinical setting?
"rituximab was first trialled in 1993 at National Institutes of Health Clinical Center. So far, there have been802 completed trials and 422 actively recruiting studies. Many of the active trials are based in Norwich, Connecticut."
Answered by AI
Are new participants being added to this research project?
"This particular study is not currently looking for patients, as can be observed by the lack of recent updates on clinicaltrials.gov. The study was originally posted on November 1st, 2003, with the most recent edit being on June 8th, 2022. There are, however, 2204 other clinical trials that are currently recruiting."
Answered by AI
To what conditions is rituximab most often given as a treatment?
"Rituximab is a medication used to treat a wide variety of diseases, including dlbcl, b-cell lymphomas, polyangium, and pemphigus vulgaris."
Answered by AI
Are there any limits to how many people can join this clinical trial?
"As of now, this clinical trial is no longer looking for new patients to enroll. This study was first posted on November 1st, 2003 and was most recently edited on June 8th, 2022. There are currently 1782 trials actively recruiting patients with lymphoma and 422 trials using rituximab that are still looking for patients."
Answered by AI
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