Obinutuzumab for Follicular Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Follicular Lymphoma+12 MoreObinutuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new immunotherapy treatment for previously untreated follicular lymphoma. The treatment consists of two drugs, obinutuzumab and lenalidomide. The trial will test how well the two drugs work together to treat the cancer.

Eligible Conditions
  • Lymphoma
  • Follicular Lymphoma
  • Enlarged Spleen
  • Night Sweats
  • Weight Loss
  • Fever
  • Fatigue

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

At 120 weeks
Complete response
Year 3
Overall survival
Year 3
Event free survival
Year 3
Duration of response
Year 2
Progression free survival
Up to 3 years
Overall response rate (CR + partial response [PR])

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

CLB+OB
63%Neutropenia
53%Infusion related reaction
30%Nausea
25%Anaemia
25%Thrombocytopenia
24%Pyrexia
17%Fatigue
15%Asthenia
13%Dyspnoea
12%Cough
12%Constipation
12%Vomiting
11%Headache
10%Arthralgia
10%Diarrhea
10%Back pain
9%Chills
9%Pain in extremity
8%Epistaxis
7%Anxiety
7%Oedema peripheral
6%Upper respiratory tract infection
6%Vision blurred
6%Urinary tract infection
6%Dizziness
6%Hyperglycaemia
6%Tremor
6%Febrile neutropenia
6%Muscle spasms
5%Abdominal pain
5%Oral herpes
5%Hypotension
5%Weight decreased
4%Pneumonia
4%Decreased appetite
4%Insomnia
4%Tumour lysis syndrome
4%Lacrimation increased
4%Hypertension
3%Cellulitis
3%Musculoskeletal pain
3%Gastrooesophageal reflux disease
3%Herpes zoster
3%Pruritus
3%Palpitations
3%Nasopharyngitis
3%Fall
3%Myalgia
3%Oropharyngeal pain
3%Dry eye
2%Peripheral swelling
2%Hypokalaemia
2%Sepsis
2%Dyspepsia
2%Conjunctivitis
2%Bronchitis
2%Productive cough
2%Rash maculo-papular
1%Craniocerebral injury
1%Venous thrombosis limb
1%Hyponatraemia
1%Acute myocardial infarction
1%Pericarditis constrictive
1%Chronic lymphocytic leukaemia
1%Essential thrombocythaemia
1%Keratoacanthoma
1%Urinary retention
1%Respiratory failure
1%Stomatitis
1%Gastroenteritis
1%Hip fracture
1%Accidental overdose
1%Dehydration
1%Kaposi's sarcoma
1%Neuroendocrine carcinoma of the skin
1%Loss of consciousness
1%Prostate Cancer
1%Seizure
1%Acute kidney injury
1%Acute respiratory failure
1%Pulmonary embolism
1%Cataract
1%Spontaneous haematoma
1%Blood creatine increased
1%Respiratory tract infection
1%Contusion
1%Depression
1%Rash
1%Myocardial ischaemia
1%Cholecystitis
1%Small intestinal obstruction
1%Vascular device infection
1%Pharyngitis
1%Concussion
1%Osteonecrosis of jaw
1%Osteolysis
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02264574) in the CLB+OB ARM group. Side effects include: Neutropenia with 63%, Infusion related reaction with 53%, Nausea with 30%, Anaemia with 25%, Thrombocytopenia with 25%.

Trial Design

1 Treatment Group

Treatment (obinutuzumab, lenalidomide)
1 of 1

Experimental Treatment

96 Total Participants · 1 Treatment Group

Primary Treatment: Obinutuzumab · No Placebo Group · Phase 2

Treatment (obinutuzumab, lenalidomide)Experimental Group · 2 Interventions: Lenalidomide, Obinutuzumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Obinutuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,803 Previous Clinical Trials
1,790,262 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,073 Previous Clinical Trials
41,138,812 Total Patients Enrolled
Loretta J NastoupilPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able and willing to provide written informed consent and to comply with the study protocol.
You have a bi-dimensionally measurable disease, with at least one mass lesion > 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI).
At least 3 nodal or extranodal sites > 3 cm in diameter.
You have follicular lymphoma.
A nodal or extranodal (except spleen) mass > 7 cm in its greater diameter.
You have lost more than 10% of your weight in the past 6 months.