What side effects are associated with this type of intervention?

Common side effects of treatments for Follicular Non-Hodgkin Lymphoma that involve BTK inhibitors (such as BGB-3111) and CD20 targeting agents (such as obinutuzumab) include infusion-related reactions, infections, neutropenia, thrombocytopenia, anemia, and gastrointestinal symptoms like diarrhea and nausea. BTK inhibitors can also cause cardiovascular issues such as atrial fibrillation and hypertension. Patients may experience fatigue, musculoskeletal pain, and rash. It is important to monitor for these side effects and manage them appropriately in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Follicular Non-Hodgkin Lymphoma that involve BTK inhibitors and CD20 targeting agents. Ibrutinib, a BTK inhibitor, has been approved for various B-cell malignancies, including Follicular Lymphoma. Obinutuzumab, a CD20 targeting monoclonal antibody, has also been approved for use in combination with chemotherapy for Follicular Lymphoma. Other CD20 targeting agents like rituximab have been widely used in combination with various chemotherapeutic regimens. These approvals highlight the therapeutic potential of combining BTK inhibition with CD20 targeting in treating Follicular Non-Hodgkin Lymphoma.

What other types of research exist?

Promising novel alternatives to BGB-3111 plus obinutuzumab for Follicular Non-Hodgkin Lymphoma patients include: 1) Bendamustine plus rituximab (B-R), which has shown efficacy in indolent lymphomas. 2) CHOP plus rituximab (CHOP-R), a well-established regimen. 3) Ibrutinib plus rituximab, which has demonstrated increased complete response rates. 4) Venetoclax plus rituximab, targeting BCL-2 and CD20. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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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

No Placebo-Only Group

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.

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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.

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My diagnosis is B-cell follicular lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

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

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Bronchopulmonary aspergillosis

Compartment syndrome

Inclusion body myositis

Myelodysplastic syndrome

Ischaemic stroke

Malignant melanoma

Gastritis

Respiratory failure

Peripheral ischaemia

Uterine prolapse

Bronchitis chronic

Haemoptysis

Oesophageal rupture

Colorectal cancer metastatic

Pleural effusion

Concussion

Invasive ductal breast carcinoma

Colorectal cancer

Non-small cell lung cancer

Cardiac failure congestive

Arthritis

Bacterial sepsis

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2160

0 / 13Eligibility criteria met

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.