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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ROSEWOOD Trial Summary
This trial is testing a new drug to see if it is more effective than the current standard of care for relapsed or refractory follicular lymphoma, with the goal of improving outcomes for patients with this disease.
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.Check my eligibility
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.See study design
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.
ROSEWOOD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after my last treatment or is not responding to treatment.
Select...
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.
Select...
My cancer can be measured by tests.
Select...
I have been treated with an anti-CD20 antibody and a specific chemotherapy.
Select...
My diagnosis is B-cell follicular lymphoma.
ROSEWOOD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) as Assessed by Independent Central Review
Secondary outcome measures
Complete Metabolic Response Rate
Complete Response Rate
Duration of response (DOR)
+7 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%
Bronchopulmonary aspergillosis
1%
Malignant melanoma
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Acute myocardial infarction
1%
Leukopenia
1%
Concussion
1%
Invasive ductal breast carcinoma
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Myelodysplastic syndrome
1%
Non-small cell lung cancer
1%
Bronchitis chronic
1%
Haemoptysis
1%
Oesophageal rupture
1%
Arthritis
1%
Respiratory failure
1%
Colorectal cancer
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
ROSEWOOD Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Approximately 70 subjects to receive obinutuzumab
Group II: Arm AExperimental Treatment2 Interventions
Approximately 140 subjects to receive BGB-3111 and obinutuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Zanubrutinib
2017
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,597 Total Patients Enrolled
William Reed, MDStudy DirectorBeiGene
2 Previous Clinical Trials
282 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a serious infection.My condition worsened after my last treatment or is not responding to treatment.I can take care of myself and am up and about more than half of my waking hours.I have been treated with a BTK inhibitor before.I have a serious heart condition.I have had at least 2 treatments for follicular lymphoma.My follicular lymphoma has changed into a more aggressive type.I had a stem cell transplant from a donor within the last year.I haven't had cancer in the last 2 years, except for certain non-aggressive types.My cancer can be measured by tests.I have been treated with an anti-CD20 antibody and a specific chemotherapy.My diagnosis is B-cell follicular lymphoma.My kidney and liver are working well.I have a history of severe bleeding problems.I have not had major surgery or a significant injury in the last 4 weeks.My leukemia or lymphoma has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
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.
Does this experiment include elderly participants over the age of 85?
"According to the trial's predetermined parameters, individuals between 18-99 years old may be eligible for this clinical investigation."
Answered by AI
Are there any Canadian sites that are currently administering this scientific experiment?
"The current trial is running from 11 different clinical locations, including Jewish General Hospital in Montréal, Quebec, Loyola University Medical Center in Maywood, Illinois and University of Illinois Hospital & Health Sciences System in Chicago."
Answered by AI
Is this a pioneering clinical trial?
"Obinutuzumab has been subject to 134 live studies across 1092 cities in 49 countries. The first trial of this drug, sponsored by Genentech Inc., took place in 2014 and involved 40 patients completing the Phase 1 & 2 phases of drug approval. Since then, 74 trials have concluded their research."
Answered by AI
To what extent is this medical experiment being implemented among patients?
"This research program is no longer enrolling patients. It was posted on November 15th, 2017 and last updated February 23rd 2022. If you are still looking for a trial to join, there are 1751 studies recruiting participants with lymphoma follicular and 134 trials actively taking in candidates for Obinutuzumab treatment."
Answered by AI
What evidence exists that suggests Obinutuzumab is a safe treatment for patients?
"Based on the Phase 2 status of Obinutuzumab, our team at Power has assigned it a score of 2 for safety. This means that although there is some evidence to support its security, no research exists demonstrating effectiveness in this regard yet."
Answered by AI
Would I qualify to participate in this research?
"Eligible for this trial are patients with follicular lymphoma, aged between 18 and 99. Thus far, a total of 217 participants have been enrolled in the study."
Answered by AI
Are there any research reports that discuss the use of Obinutuzumab?
"Initially studied in 2014 at the UCSD Moores Cancer Center, obinutuzumab has now been subject to 74 completed trials. Additionally, there are presently 134 active studies recruiting patients from Montréal and other locations across Canada."
Answered by AI
Are there currently any openings for participation in this clinical trial?
"Sign-ups for this trial are no longer being accepted. The original posting was on November 15th, 2017 and it underwent its latest edit on February 23rd, 2022. If you're searching for alternative studies involving lymphoma or obinutuzumab specifically, there are 1751 and 134 trials respectively that are still recruiting."
Answered by AI
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