Your session is about to expire
← Back to Search
Immunomodulatory Agent
Obinutuzumab + Lenalidomide for Follicular Lymphoma
Phase 2
Waitlist Available
Led By Loretta J Nastoupil
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative pregnancy test for women of childbearing potential
Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by CT, PET/CT, and/or MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with untreated stage II-IV grade 1-3a follicular lymphoma. Participants must have measurable disease, be in need of treatment, and have an ECOG performance status of <=2. They should not be pregnant or breastfeeding and must use reliable contraception. Exclusions include a history of other cancers (unless disease-free for 5 years), serious illnesses, certain heart conditions, prior lenalidomide use, active infections like HIV or hepatitis B/C.Check my eligibility
What is being tested?
The trial tests the combination of obinutuzumab (an immunotherapy) and lenalidomide (a chemotherapy drug) to see if they are more effective when used together in treating patients who haven't had previous treatments for follicular lymphoma.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's activation by obinutuzumab, such as infusion reactions or organ inflammation. Lenalidomide can cause blood disorders, fatigue, digestive issues and increase the risk of developing new cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant.
Select...
I have a tumor that is at least 2 cm large, confirmed by imaging tests.
Select...
I have been diagnosed with a type of lymphoma (grades 1, 2, or 3a) and have not received treatment.
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
Progression free survival
Secondary outcome measures
Complete response
Duration of response
Event free survival
+2 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%
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%
Myelodysplastic syndrome
1%
Haemoptysis
1%
Respiratory failure
1%
Colorectal cancer
1%
Bronchopulmonary aspergillosis
1%
Malignant melanoma
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Acute myocardial infarction
1%
Concussion
1%
Non-small cell lung cancer
1%
Invasive ductal breast carcinoma
1%
Leukopenia
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Bronchitis chronic
1%
Oesophageal rupture
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (obinutuzumab, lenalidomide)Experimental Treatment2 Interventions
Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,225 Total Patients Enrolled
14 Trials studying Fever
642 Patients Enrolled for Fever
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,977 Total Patients Enrolled
13 Trials studying Fever
4,381 Patients Enrolled for Fever
Loretta J NastoupilPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
99 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is Grade 3b follicular lymphoma.I have recently received a live vaccine.My lab results and cancer stage meet the study's requirements.I have active cancer in my brain or spinal cord.I have previously taken lenalidomide.I am currently on medication that suppresses my immune system.I am not pregnant.I have a serious heart condition.I need treatment for my lymphoma due to large tumors, symptoms like fever or weight loss, or low blood counts.I have had major surgery recently.I have had cancer before, but it meets the trial's exception criteria.I have a specific blood clotting condition.My follicular lymphoma has transformed into a more aggressive form.I have a tumor that is at least 2 cm large, confirmed by imaging tests.I have a serious illness or organ problem.I have been diagnosed with a type of lymphoma (grades 1, 2, or 3a) and have not received treatment.I am registered and comply with the Revlimid REMS program.I do not have HIV, active hepatitis B or C, or any uncontrolled infections.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (obinutuzumab, lenalidomide)
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.
In what conditions is Obinutuzumab typically prescribed?
"Obinutuzumab has the capacity to alleviate the symptoms of amyloidosis, lymphoma and refractory diffuse large b cell lymphoma (dlbcl)."
Answered by AI
How many individuals are engaged in the research?
"As of now, this medical trial is not seeking any more participants. The research was initially posted on December 6th 2016 and the latest update occurred October 31st 2022. If you want to look for other studies, there are 2244 trials recruiting patients with fever and 361 accepting Obinutuzumab study volunteers."
Answered by AI
What prior studies have been conducted using Obinutuzumab?
"Currently, there are 361 ongoing studies related to Obinutuzumab with 74 in the third phase. Although Detroit is a hub for research on this drug, it can be found at 18054 locations across the globe."
Answered by AI
Has Obinutuzumab received regulatory authorization from the U.S. Food and Drug Administration?
"Whilst limited data exists in relation to its efficacy, Obinutuzumab's safety is supported by some clinical studies and thus received a rating of 2."
Answered by AI
Are there any vacancies remaining in this trial for prospective participants?
"The clinical trial data hosted on clinicialtrials.gov reveals that this research is no longer enrolling participants, having originally been posted in December 2016 and last updated October 2022. However, 2605 other trials can be found which are currently recruiting patients."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger