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Kinase Inhibitor
Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas
Phase 2
Recruiting
Led By Ubaldo Martinez-Outschoorn, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
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 two years
Awards & highlights
Summary
This trial is testing a new therapy for non-Hodgkin's lymphoma that could be more effective than current treatments.
Who is the study for?
This trial is for adults with untreated indolent non-Hodgkin's lymphoma, including various types of marginal zone and follicular lymphomas. Participants must have measurable disease, be able to swallow pills, and not have severe liver failure or other serious health conditions. Women of childbearing potential need a negative pregnancy test and agree to use effective contraception.
What is being tested?
The study tests the combination of obinutuzumab (a monoclonal antibody) and ibrutinib (an enzyme blocker) as initial treatment for patients with certain types of slow-growing non-Hodgkin's lymphoma. The goal is to see if this drug combo can stop cancer cells from growing by interfering with their function.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, infections due to weakened immune system, bleeding problems, heart issues like arrhythmias or heart failure, liver problems in those already at risk, fatigue, digestive issues such as nausea or diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate in patients with newly diagnosed indolent lymphoma requiring treatment, including complete response and partial response
Secondary study objectives
Incidence of grade III-IV toxicity
Overall survival
Partial remission or complete remission in patients treated with ibrutinib and obinutuzumab
+1 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Insomnia
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Gingival bleeding
5%
Mouth ulceration
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
5%
Petechiae
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Dysuria
3%
Tinnitus
3%
Rotator cuff syndrome
3%
Pollakiuria
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Wheezing
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib, obinutuzumab)Experimental Treatment3 Interventions
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.
After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Ibrutinib
FDA approved
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,881 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,334 Total Patients Enrolled
1 Trials studying MALT Lymphoma
26 Patients Enrolled for MALT Lymphoma
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,778 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active hepatitis B.I have symptoms or conditions due to my lymphoma that require treatment.I have a type of slow-growing non-Hodgkin's lymphoma known as follicular lymphoma.My MZL cancer requires systemic therapy and has been confirmed with a biopsy.I haven't had a major infection or been on IV antibiotics in the last 4 weeks.I have hepatitis B but agree to treatment and monitoring while receiving obinutuzumab.I've had lymphoma treatment but stopped steroids 2 weeks ago and am not allergic to obinutuzumab or ibrutinib.My lymphoma has spread to my brain or spinal cord.I do not have a history of uncontrolled seizures.I have a known bleeding disorder, like von Willebrand's or hemophilia.I do not have viral hepatitis.I've been cancer-free for 5 years, except for certain skin, cervical, breast, prostate, or bladder cancers treated curatively.My condition has not transformed into large B cell disease.I do not have serious heart problems or recent heart attacks.I haven't had chemotherapy for another cancer in the last 2 years.I do not have active or uncontrolled immune-related blood disorders.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I do not need blood transfusions for low platelet counts or have bleeding problems.I do not have an autoimmune disorder needing ongoing immunosuppression.I can follow the study's rules or have someone who can ensure I do.I am a woman who cannot become pregnant or I have a negative pregnancy test.I agree to use effective birth control and a barrier method during and after treatment.My gastric MZL cancer is advanced, affecting areas beyond its origin.I haven't had a stroke or brain bleed in the last 6 months.My condition is a type of follicular lymphoma.I am not pregnant, have tested negative for pregnancy, and will use birth control during and after the treatment.My condition requires treatment based on standard GELF criteria.My condition is marginal zone lymphoma.My disease is at stage II, III, or IV.My cancer cells test positive for CD20.I am able to care for myself and perform daily activities.I have symptoms or complications from lymphoma, including large tumors or spleen enlargement.My skin lymphoma has spread beyond the skin.I have nodal or splenic marginal zone lymphoma and need systemic therapy.My condition is extranodal marginal zone lymphoma.I am currently taking warfarin or similar blood thinners.I have Hepatitis C but my viral load is undetectable.I need treatment with a strong medication that affects liver enzymes.I received a live vaccine at least 28 days before starting treatment.My lymphoma is a type that grows slowly and hasn't been treated yet.I have severe liver problems.I have MZL and need treatment that affects my whole body.My MZL is not in the stomach or skin and needs treatment.My kidneys work well enough, with a creatinine clearance of 30 ml/min or more.My liver functions well and is not in a state of severe failure.I am HIV or HTLV-1 positive.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, obinutuzumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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