Study Summary
This trial is testing a new combination of drugs to treat patients with previously untreated follicular lymphoma. The drugs may work better together than each one alone.
Eligible Conditions
- Follicular Lymphoma Grade 2
- Follicular Lymphoma
- Follicular Lymphoma Grade 1
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: At 30 months (120 weeks)
At 12 months
Complete response (CR) rate
Month 30
CR rate
Year 2
Overall survival
Year 2
Time to next anti-lymphoma treatment
Year 2
Progression-free survival
Year 2
Duration of response
Year 2
Overall response rate (ORR)
Day 30
Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions
Frequency, severity, and relatedness of treatment-emergent adverse events (AEs)
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Side Effects for
IBR+OB
44%Neutropenia
35%Diarrhea
35%Thrombocytopenia
29%Cough
24%Arthralgia
23%Infusion related reaction
19%Back pain
19%Fatigue
19%Hypertension
17%Constipation
17%Anaemia
17%Pyrexia
16%Upper respiratory tract infection
15%Rash maculo-papular
14%Muscle spasms
14%Atrial fibrillation
13%Hyperuricaemia
13%Nausea
13%Nasopharyngitis
12%Oedema peripheral
12%Urinary tract infection
12%Insomnia
11%Vomiting
11%Asthenia
11%Conjunctivitis
11%Pneumonia
11%Pain in extremity
11%Dizziness
11%Dyspnoea
10%Cataract
10%Decreased appetite
9%Spontaneous haematoma
9%Fall
9%Anxiety
9%Rash
8%Abdominal pain
8%Vision blurred
8%Dyspepsia
8%Headache
8%Iron deficiency
8%Pruritus
7%Lacrimation increased
7%Gastrooesophageal reflux disease
7%Bronchitis
7%Respiratory tract infection
7%Blood creatine increased
7%Productive cough
7%Oropharyngeal pain
6%Dry eye
6%Hypokalaemia
6%Palpitations
6%Myalgia
6%Stomatitis
6%Chills
6%Peripheral swelling
6%Depression
6%Epistaxis
6%Dry Skin
6%Ecchymosis
6%Onychoclasis
5%Hyperglycaemia
5%Herpes zoster
5%Contusion
5%Haematuria
5%Petechiae
5%Cellulitis
5%Musculoskeletal pain
5%Increased tendency to bruise
4%Febrile neutropenia
4%Tremor
3%Gastroenteritis
3%Acute coronary syndrome
3%Weight decreased
3%Adenocarcinoma of colon
2%Angina pectoris
2%Cardiac arrest
2%Septic shock
2%Cerebrovascular accident
2%Transient ischaemic attack
2%Acute kidney injury
2%Renal failure
2%Death
2%Femur fracture
2%Osteoarthritis
1%Benign renal neoplasm
1%Colorectal cancer metastatic
1%Traumatic haematoma
1%Spinal compression fracture
1%Thoracic vertebral fracture
1%Upper limb fracture
1%Stress cardiomyopathy
1%Goitre
1%Rib fracture
1%Colorectal cancer
1%Malignant melanoma
1%Myelodysplastic syndrome
1%Osteoma
1%Cardiac failure congestive
1%Pericarditis
1%Oesophageal rupture
1%Escherichia urinary tract infection
1%Listeria sepsis
1%Incisional hernia
1%Herpes Zoster
1%Myocardial infarction
1%Infective aneurysm
1%Pharyngitis
1%Escherichia sepsis
1%Pubis fracture
1%Non-small cell lung cancer
1%Aplastic anaemia
1%Leukopenia
1%Acute myocardial infarction
1%Atrial tachycardia
1%Retinal detachment
1%Haemorrhoids
1%Inguinal hernia
1%Proctitis
1%Small intestinal obstruction
1%Catheter site haematoma
1%Multi-organ disorder
1%Sudden Death
1%Cholelithiasis
1%Abscess
1%Bacterial sepsis
1%Bronchopulmonary aspergillosis
1%Bursitis infective staphylococcal
1%Erysipelas
1%Pneumocystis jirovecii pneumonia
1%Pneumonia bacterial
1%Pneumonia klebsiella
1%Prostate infection
1%Sinusitis fungal
1%Soft tissue infection
1%Streptococcal bacteraemia
1%Urosepsis
1%Diabetes mellitus inadequate control
1%Hypercalcaemia
1%Arthritis
1%Compartment syndrome
1%Inclusion body myositis
1%Adenocarcinoma gastric
1%Basal cell carcinoma
1%Invasive ductal breast carcinoma
1%Squamous cell carcinoma
1%Cerebral ischaemia
1%Depressed level of consciousness
1%Ischaemic stroke
1%Syncope
1%Acute psychosis
1%Complete Suicide
1%Confusional state
1%Nephrolithiasis
1%Urinary retention
1%Benign prostatic hyperplasia
1%Uterine prolapse
1%Bronchitis chronic
1%Haemoptysis
1%Pleural effusion
1%Respiratory failure
1%Peripheral ischaemia
1%Oral herpes
1%Hypotension
1%Cardiac failure
1%Large intestine polyp
1%Gastritis
1%Impaired gastric emptying
1%Lower respiratory tract infection
1%Jaw fracture
1%Concussion
1%Hypomagnesaemia
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1 Treatment Group
Treatment (obinutuzumab, venetoclax, ibrutinib)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Obinutuzumab · No Placebo Group · Phase 2
Treatment (obinutuzumab, venetoclax, ibrutinib)Experimental Group · 3 Interventions: Obinutuzumab, Ibrutinib, Venetoclax · Intervention Types: Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Ibrutinib
FDA approved
Venetoclax
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 30 months (120 weeks)
Who is running the clinical trial?
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,281 Previous Clinical Trials
41,235,086 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
112 Previous Clinical Trials
14,087 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,513 Previous Clinical Trials
568,236 Total Patients Enrolled
Joseph M TuscanoPrincipal InvestigatorUniversity of California, Davis
4 Previous Clinical Trials
115 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have one or more of the following symptoms: fever not caused by infection, night sweats, significant weight loss in the past 6 months, fatigue due to lymphoma, enlarged spleen, and compression of organs such as ureter, orbit, or gastrointestinal tract.
You must require treatment, which will be determined based on at least one of the following criteria:
Frequently Asked Questions
Can you provide examples of previous investigations involving Obinutuzumab?
"Currently, 400 clinical studies are exploring the efficacy of Obinutuzumab. Out of these trials, 52 have reached Phase 3 status. Despite being predominantly situated in Edmonton Alberta, 13115 medical facilities across the world host experiments for this treatment." - Anonymous Online Contributor
Unverified Answer
How many participants are receiving treatment in this research project?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is currently enrolling individuals, with the original posting date on February 24th 2021 and latest update October 24th 2022. 40 participants are needed between two medical sites." - Anonymous Online Contributor
Unverified Answer
Is Obinutuzumab a risk to human health?
"Our safety rating for Obinutuzumab is a 2 as there is some evidence of its security, however no clinical data exists that supports efficacy." - Anonymous Online Contributor
Unverified Answer
For which pathologies is Obinutuzumab a preferred treatment?
"Through the utilization of Obinutuzumab, small lymphocytic lymphoma, leukemic lymphoid cells and Waldenstrom Macrolobulinemia can be managed." - Anonymous Online Contributor
Unverified Answer
Is there presently an open invitation to join this clinical research?
"Clinicaltrials.gov documents verify that this research project is presently recruiting participants, with the initial posting on February 24th 2021 and most recent update October 24th 2022." - Anonymous Online Contributor
Unverified Answer