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Monoclonal Antibodies

Obinutuzumab + Zanubrutinib for Follicular Lymphoma (ROSEWOOD Trial)

Phase 2
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease progression after completion of most recent therapy or refractory disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
Must not have
Active fungal, bacterial or viral infection requiring systemic treatment
Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights

Summary

This trial is testing if a combination of two drugs works better than one drug alone for patients with a type of lymphoma that has returned or resisted treatment. One drug stops cancer growth, and the other helps the immune system kill cancer cells.

Who is the study for?
This trial is for people with relapsed/refractory non-Hodgkin follicular lymphoma who have had at least two prior treatments, including an anti-CD20 antibody and alkylator therapy. They must have measurable disease, adequate organ function, and a performance status of 0 to 2. Those with aggressive lymphoma transformation, recent major surgery or other cancers (with some exceptions), or past BTK inhibitor treatment can't join.
What is being tested?
The study compares the effectiveness of combining Obinutuzumab (a monoclonal antibody) with Zanubrutinib (BGB-3111), a Bruton's tyrosine kinase inhibitor, against using Obinutuzumab alone in participants with refractory/relapsed follicular lymphoma to see which is better at treating the condition.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal tests, fatigue, nausea. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after my last treatment or is not responding to treatment.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have had at least 2 treatments for follicular lymphoma.
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My cancer can be measured by tests.
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I have been treated with an anti-CD20 antibody and a specific chemotherapy.
Select...
My diagnosis is B-cell follicular lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently being treated for a serious infection.
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I have been treated with a BTK inhibitor before.
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I have a serious heart condition.
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My follicular lymphoma has changed into a more aggressive type.
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I had a stem cell transplant from a donor within the last year.
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I have a history of severe bleeding problems.
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My leukemia or lymphoma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

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 (ORR) by Independent Review Committee (IRC) Assessment
Secondary study objectives
Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs)

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574
44%
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%
Headache
8%
Iron deficiency
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%
Adenocarcinoma of colon
3%
Acute coronary syndrome
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%
Pleural effusion
1%
Concussion
1%
Oesophageal rupture
1%
Bacterial sepsis
1%
Bronchitis chronic
1%
Colorectal cancer
1%
Malignant melanoma
1%
Myelodysplastic syndrome
1%
Bronchopulmonary aspergillosis
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Respiratory failure
1%
Gastritis
1%
Haemoptysis
1%
Peripheral ischaemia
1%
Leukopenia
1%
Acute myocardial infarction
1%
Cardiac failure congestive
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Non-small cell lung cancer
1%
Ischaemic stroke
1%
Uterine prolapse
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

2Treatment groups
Experimental Treatment
Group I: Zanubrutinib + ObinutuzumabExperimental Treatment2 Interventions
Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
Group II: ObinutuzumabExperimental Treatment1 Intervention
Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3470
Zanubrutinib
2017
Completed Phase 3
~1940

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Follicular Non-Hodgkin Lymphoma (FNHL) include Bruton Tyrosine Kinase (BTK) inhibitors and CD20-targeting monoclonal antibodies. BTK inhibitors, such as BGB-3111, block the BTK enzyme, which is crucial for the survival and proliferation of B-cells, thereby reducing the growth of lymphoma cells. CD20-targeting agents like obinutuzumab bind to the CD20 protein on the surface of B-cells, marking them for destruction by the immune system. These mechanisms are significant for FNHL patients as they directly target the malignant B-cells, leading to more effective and specific treatment outcomes with potentially fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
188 Previous Clinical Trials
29,868 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,252 Previous Clinical Trials
504,162 Total Patients Enrolled
William Reed, MDStudy DirectorBeiGene
2 Previous Clinical Trials
282 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03332017 — Phase 2
Follicular Non-Hodgkin Lymphoma Research Study Groups: Obinutuzumab, Zanubrutinib + Obinutuzumab
Follicular Non-Hodgkin Lymphoma Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT03332017 — Phase 2
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03332017 — Phase 2
~28 spots leftby Sep 2025
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