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Monoclonal Antibodies

Obinutuzumab-Based Therapy for Follicular Lymphoma

Phase 2
Recruiting
Led By Paul M Barr
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible
Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with grade I-IIIa follicular lymphoma that has relapsed or is refractory. Eligible participants must have had only one prior chemotherapy regimen, be at least 18 years old, and have adequate organ function. They should not have CNS involvement by lymphoma or previous treatment with PI3K inhibitors or lenalidomide.Check my eligibility
What is being tested?
The study tests obinutuzumab alone or combined with umbralisib, lenalidomide, or other chemotherapies to see which works best for treating relapsed/refractory follicular lymphoma. It explores how these treatments affect the immune system's ability to fight cancer and stop tumor growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's activation (like flu-like symptoms), effects from cell death (nausea, fatigue), possible increased risk of infections due to immune suppression, and specific drug-related risks like liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received anti-CD20 antibody therapy before CHOP or bendamustine treatment.
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I've had one round of chemotherapy with CHOP or bendamustine.
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I have managed hepatitis B or C, or HIV with no liver damage.
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I had a full medical check-up in the last 28 days.
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I have grade I, II, or IIIa follicular lymphoma with FDG-avid disease, and no large cell lymphoma involvement.
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My cancer returned or didn't fully respond within 2 years after my last CHOP or bendamustine treatment, without any other chemotherapy in between.
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My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am willing and able to take blood clot prevention medication if needed.
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I am 18 years old or older.
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My heart's pumping ability is confirmed to be good by a recent heart scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR)
Secondary outcome measures
Active lymphoma and circulating tumor DNA in plasma
Duration of response (CR, partial response [PR])
Incidence of adverse events
+5 more

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
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%
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%
Myelodysplastic syndrome
1%
Bronchitis chronic
1%
Haemoptysis
1%
Oesophageal rupture
1%
Respiratory failure
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (obinutuzumab, lenalidomide)Experimental Treatment8 Interventions
Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.
Group II: Arm I (obinutuzumab, umbralisib)Experimental Treatment8 Interventions
CLOSED TO ACCRUAL: Patients receive obinutuzumab IV on day 1 and umbralisib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.
Group III: Arm III (obinutuzumab, combination chemotherapy)Active Control12 Interventions
PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Obinutuzumab
2015
Completed Phase 3
~3250
Biopsy
2014
Completed Phase 4
~1090
Positron Emission Tomography
2008
Completed Phase 2
~2240
Echocardiography
2013
Completed Phase 4
~11670
Umbralisib
2015
Completed Phase 2
~60
Computed Tomography
2017
Completed Phase 2
~2720
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,553 Total Patients Enrolled
Paul M BarrPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03269669 — Phase 2
Follicular Lymphoma Research Study Groups: Arm III (obinutuzumab, combination chemotherapy), Arm II (obinutuzumab, lenalidomide), Arm I (obinutuzumab, umbralisib)
Follicular Lymphoma Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT03269669 — Phase 2
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03269669 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
2018. "Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03269669.
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