Study Summary
This trial is testing obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy to treat patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment.
Eligible Conditions
- Follicular Lymphoma Grade 1
- Follicular Lymphoma Grade 2
- Follicular Lymphoma
- Recurrent Follicular Lymphoma
- Refractory Follicular Lymphoma
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Up to 5 years
Month 30
Active lymphoma and circulating tumor DNA in plasma
Year 5
Duration of response (CR, partial response [PR])
Year 5
Progression-free survival (PFS)
Up to 30 months
Sustained complete response rate (CR30)
Up to 5 years
Incidence of adverse events
DNA
Overall survival (OS)
m7-FLIPI model validation
Up to 6 cycles
Complete response (CR)
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Side Effects for
IBR+OB
44%Neutropenia
35%Diarrhea
35%Thrombocytopenia
29%Cough
24%Arthralgia
23%Infusion related reaction
19%Back pain
19%Fatigue
19%Hypertension
17%Constipation
17%Anaemia
17%Pyrexia
16%Upper respiratory tract infection
15%Rash maculo-papular
14%Muscle spasms
14%Atrial fibrillation
13%Hyperuricaemia
13%Nausea
13%Nasopharyngitis
12%Oedema peripheral
12%Urinary tract infection
12%Insomnia
11%Vomiting
11%Asthenia
11%Conjunctivitis
11%Pneumonia
11%Pain in extremity
11%Dizziness
11%Dyspnoea
10%Cataract
10%Decreased appetite
9%Spontaneous haematoma
9%Fall
9%Anxiety
9%Rash
8%Abdominal pain
8%Vision blurred
8%Dyspepsia
8%Headache
8%Iron deficiency
8%Pruritus
7%Lacrimation increased
7%Gastrooesophageal reflux disease
7%Bronchitis
7%Respiratory tract infection
7%Blood creatine increased
7%Productive cough
7%Oropharyngeal pain
6%Dry eye
6%Hypokalaemia
6%Palpitations
6%Myalgia
6%Stomatitis
6%Chills
6%Peripheral swelling
6%Depression
6%Epistaxis
6%Dry Skin
6%Ecchymosis
6%Onychoclasis
5%Hyperglycaemia
5%Herpes zoster
5%Contusion
5%Haematuria
5%Petechiae
5%Cellulitis
5%Musculoskeletal pain
5%Increased tendency to bruise
4%Febrile neutropenia
4%Tremor
3%Gastroenteritis
3%Acute coronary syndrome
3%Weight decreased
3%Adenocarcinoma of colon
2%Angina pectoris
2%Cardiac arrest
2%Septic shock
2%Cerebrovascular accident
2%Transient ischaemic attack
2%Acute kidney injury
2%Renal failure
2%Death
2%Femur fracture
2%Osteoarthritis
1%Benign renal neoplasm
1%Colorectal cancer metastatic
1%Traumatic haematoma
1%Spinal compression fracture
1%Thoracic vertebral fracture
1%Upper limb fracture
1%Stress cardiomyopathy
1%Goitre
1%Rib fracture
1%Colorectal cancer
1%Malignant melanoma
1%Myelodysplastic syndrome
1%Osteoma
1%Cardiac failure congestive
1%Pericarditis
1%Oesophageal rupture
1%Escherichia urinary tract infection
1%Listeria sepsis
1%Incisional hernia
1%Herpes Zoster
1%Myocardial infarction
1%Infective aneurysm
1%Pharyngitis
1%Escherichia sepsis
1%Pubis fracture
1%Non-small cell lung cancer
1%Aplastic anaemia
1%Leukopenia
1%Acute myocardial infarction
1%Atrial tachycardia
1%Retinal detachment
1%Haemorrhoids
1%Inguinal hernia
1%Proctitis
1%Small intestinal obstruction
1%Catheter site haematoma
1%Multi-organ disorder
1%Sudden Death
1%Cholelithiasis
1%Abscess
1%Bacterial sepsis
1%Bronchopulmonary aspergillosis
1%Bursitis infective staphylococcal
1%Erysipelas
1%Pneumocystis jirovecii pneumonia
1%Pneumonia bacterial
1%Pneumonia klebsiella
1%Prostate infection
1%Sinusitis fungal
1%Soft tissue infection
1%Streptococcal bacteraemia
1%Urosepsis
1%Diabetes mellitus inadequate control
1%Hypercalcaemia
1%Arthritis
1%Compartment syndrome
1%Inclusion body myositis
1%Adenocarcinoma gastric
1%Basal cell carcinoma
1%Invasive ductal breast carcinoma
1%Squamous cell carcinoma
1%Cerebral ischaemia
1%Depressed level of consciousness
1%Ischaemic stroke
1%Syncope
1%Acute psychosis
1%Complete Suicide
1%Confusional state
1%Nephrolithiasis
1%Urinary retention
1%Benign prostatic hyperplasia
1%Uterine prolapse
1%Bronchitis chronic
1%Haemoptysis
1%Pleural effusion
1%Respiratory failure
1%Peripheral ischaemia
1%Oral herpes
1%Hypotension
1%Cardiac failure
1%Large intestine polyp
1%Gastritis
1%Impaired gastric emptying
1%Lower respiratory tract infection
1%Jaw fracture
1%Concussion
1%Hypomagnesaemia
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
Trial Design
3 Treatment Groups
Arm III (obinutuzumab, combination chemotherapy)
1 of 3
Arm II (obinutuzumab, lenalidomide)
1 of 3
Arm I (obinutuzumab, umbralisib)
1 of 3
Active Control
Experimental Treatment
95 Total Participants · 3 Treatment Groups
Primary Treatment: Obinutuzumab · No Placebo Group · Phase 2
Arm II (obinutuzumab, lenalidomide)Experimental Group · 8 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Echocardiography, Lenalidomide, Multigated Acquisition Scan, Positron Emission Tomography, Obinutuzumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Procedure, Procedure, Biological
Arm I (obinutuzumab, umbralisib)Experimental Group · 8 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Echocardiography, Multigated Acquisition Scan, Positron Emission Tomography, Umbralisib, Obinutuzumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Procedure, Procedure, Drug, Biological
Arm III (obinutuzumab, combination chemotherapy)ActiveComparator Group · 12 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Doxorubicin Hydrochloride, Echocardiography, Multigated Acquisition Scan, Positron Emission Tomography, Prednisone, Vincristine Sulfate, Cyclophosphamide, Bendamustine Hydrochloride, Obinutuzumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Procedure, Procedure, Procedure, Drug, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Echocardiography
2013
Completed Phase 4
~11830
Lenalidomide
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2290
Umbralisib
FDA approved
Obinutuzumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,282 Previous Clinical Trials
41,235,258 Total Patients Enrolled
Paul M BarrPrincipal InvestigatorSWOG Cancer Research Network
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have previously received a combination of rituximab and bendamustine for treatment, with rituximab given first.