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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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 • NCT01126541
20%
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%
Upper respiratory tract infection
3%
Limb injury
3%
Fungal skin infection
3%
Feeling hot
3%
Osteoarthritis
3%
Arthralgia
3%
Bronchopneumonia
3%
Musculoskeletal pain
3%
Arthritis
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%
Angioedema
2%
Oedema
2%
Arthropathy
2%
Toe deformity
2%
Gastroenteritis viral
2%
Pyelonephritis acute
2%
Rheumatoid nodule
2%
Bursitis
2%
Tendonitis
2%
Viral upper respiratory tract infection
2%
Hypertriglyceridaemia
2%
Calculus bladder
2%
Viral infection
2%
Bone pain
2%
Synovitis
2%
Oedema peripheral
2%
Chest discomfort
2%
Tendon rupture
2%
Ankle fracture
2%
Rib fracture
2%
Traumatic haematoma
2%
Humerus fracture
2%
Procedural pain
2%
Stress fracture
2%
Wrist fracture
2%
Obesity
2%
Chalazion
2%
Visual acuity reduced
2%
Anaemia
2%
Lymphadenopathy
2%
Thrombocythaemia
2%
Bowen's disease
2%
Spinal compression fracture
2%
Oral herpes
2%
Restless legs syndrome
2%
Pain
2%
Rotator cuff syndrome
2%
Vulvovaginal mycotic infection
2%
Prostate infection
2%
Cellulitis
2%
Chronic sinusitis
2%
Abdominal wall abscess
2%
Pertussis
2%
Myalgia
2%
Monarthritis
2%
Osteopenia
2%
Cervical root pain
2%
Gastric ulcer
2%
Pharyngeal oedema
2%
Chest injury
2%
Cervicobrachial syndrome
2%
Pharyngeal erythema
2%
Memory impairment
2%
Dyspnoea
2%
Eczema nummular
2%
Hyperglycaemia
2%
Keratoconjunctivitis sicca
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
151,050 Total Patients Enrolled
25 Trials studying Lymphoma
7,126 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,769 Total Patients Enrolled
1,392 Trials studying Lymphoma
381,917 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
~26 spots leftby Jun 2025
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