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Kinase Inhibitor
Triple Drug Therapy for Follicular Lymphoma
Phase 2
Recruiting
Led By Joseph M Tuscano
Research Sponsored by Joseph Tuscano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
Bulky disease defined as: A nodal or extranodal (except spleen) mass > 7 cm in its greater diameter or, At least 3 nodal or extranodal sites >= 3 cm in diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with previously untreated stage II-IV follicular lymphoma. Participants must have measurable disease, not be pregnant or breastfeeding, and agree to use reliable contraception. They should not have severe illnesses that could interfere with the study, known HIV or hepatitis infections, significant heart conditions, or a history of certain other malignancies.Check my eligibility
What is being tested?
The trial tests a combination of three drugs: Obinutuzumab (an immunotherapy), Ibrutinib and Venetoclax (both target enzymes needed for cancer cell growth). It aims to see if using these drugs together is more effective than when they're used separately in treating follicular lymphoma.See study design
What are the potential side effects?
Potential side effects include immune system changes leading to organ inflammation, increased risk of infection due to weakened immunity, digestive issues like nausea or diarrhea, fatigue from anemia or general energy depletion, liver enzyme alterations indicating potential liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have untreated follicular lymphoma.
Select...
My cancer has a large tumor over 7 cm or at least 3 tumors each over 3 cm.
Select...
I have experienced fever, night sweats, significant weight loss, fatigue from lymphoma, an enlarged spleen, or compression syndrome.
Select...
I have a tumor that is at least 2 cm large, confirmed by imaging tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate
Secondary outcome measures
CR rate
Duration of response
Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions
+5 moreSide effects data
From 2019 Phase 3 trial • 229 Patients • NCT0226457444%
Neutropenia
35%
Thrombocytopenia
35%
Diarrhea
29%
Cough
24%
Arthralgia
23%
Infusion related reaction
19%
Fatigue
19%
Back pain
19%
Hypertension
17%
Anaemia
17%
Constipation
17%
Pyrexia
16%
Upper respiratory tract infection
15%
Rash maculo-papular
14%
Muscle spasms
14%
Atrial fibrillation
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Dyspnoea
11%
Vomiting
11%
Pain in extremity
11%
Dizziness
10%
Cataract
10%
Decreased appetite
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Adenocarcinoma of colon
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Colorectal cancer
1%
Bronchopulmonary aspergillosis
1%
Malignant melanoma
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Acute myocardial infarction
1%
Concussion
1%
Non-small cell lung cancer
1%
Invasive ductal breast carcinoma
1%
Leukopenia
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Myelodysplastic syndrome
1%
Bronchitis chronic
1%
Haemoptysis
1%
Oesophageal rupture
1%
Respiratory failure
1%
Peripheral ischaemia
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (obinutuzumab, venetoclax, ibrutinib)Experimental Treatment3 Interventions
Patients receive obinutuzumab IV over 60 minutes on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. Patients also receive venetoclax PO QD on days 1-28 (days 4-28 of cycle 1) and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Ibrutinib
2014
Completed Phase 3
~1880
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,033 Total Patients Enrolled
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
142 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,780 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for my condition.My condition is Grade 3b follicular lymphoma.I had major surgery less than 2 weeks ago.I have untreated follicular lymphoma.My cancer has a large tumor over 7 cm or at least 3 tumors each over 3 cm.I have experienced fever, night sweats, significant weight loss, fatigue from lymphoma, an enlarged spleen, or compression syndrome.I have a known bleeding disorder like von Willebrand's or hemophilia.I have had cancer other than follicular lymphoma but have been free of it for 5 years or more, or I had non-melanoma skin cancer or cervical carcinoma in situ that was treated successfully.I have not had a stroke or brain bleed in the last 6 months.My liver is severely impaired (Child-Pugh class C).I haven't taken strong CYP3A4 inhibitors in the last 7 days and don't need them continuously.I do not have HIV, active hepatitis B or C, or any serious infection that needed IV antibiotics or hospitalization in the last 4 weeks.I am using or willing to use two forms of birth control or practice abstinence during and after the study.I don't have any severe illnesses that could affect my safety or the study's results.I am willing and able to follow all study requirements.My heart's electrical activity is normal, excluding QT prolongation.You have had severe allergic reactions to monoclonal antibody therapy in the past, which makes it unsafe for you to receive obinutuzumab.I have a history of PML, HTLV-1, or suspected TB.I have not received any live vaccines in the last 4 weeks.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I understand the study's purpose and risks and can sign the consent form.I do not have active brain or spinal cord lymphoma.My follicular lymphoma has transformed into a more aggressive type.I am not pregnant, breastfeeding, nor planning to become pregnant or father a child during the study or within 90 days after the last dose.I have a tumor that is at least 2 cm large, confirmed by imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (obinutuzumab, venetoclax, ibrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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