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Alkylating agents

Obinutuzumab for Follicular Lymphoma

Phase 4
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy of ≥ 12 months
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to clinical cut off date (up to approximately 1.5 years)
Awards & highlights

Study Summary

This trial is studying obinutuzumab given as a short duration infusion for safety in patients with untreated advanced follicular lymphoma.

Eligible Conditions
  • Follicular Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to clinical cut off date (up to approximately 1.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to clinical cut off date (up to approximately 1.5 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
Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR
Secondary outcome measures
Complete Response (CR) Rate at 30 Months (CR30), as Assessed by the Investigator and According to the Guidelines Used at the Site
Duration (In Minutes) of Obinutuzumab Administration by Cycle
Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
+7 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%
Atrial fibrillation
14%
Muscle spasms
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%
Gastroenteritis
3%
Adenocarcinoma of colon
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%
Non-small cell lung cancer
1%
Pleural effusion
1%
Haemoptysis
1%
Malignant melanoma
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Ischaemic stroke
1%
Peripheral ischaemia
1%
Bronchopulmonary aspergillosis
1%
Leukopenia
1%
Oesophageal rupture
1%
Concussion
1%
Arthritis
1%
Inclusion body myositis
1%
Colorectal cancer
1%
Cardiac failure congestive
1%
Bacterial sepsis
1%
Invasive ductal breast carcinoma
1%
Compartment syndrome
1%
Respiratory failure
1%
Gastritis
1%
Colorectal cancer metastatic
1%
Myelodysplastic syndrome
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%
Acute myocardial infarction
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: Obinutuzumab+ChemotherapyExperimental Treatment6 Interventions
Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator is free to choose the chemotherapy for each patient. Obinutuzumab and chemotherapy is administered during induction phase and obinutuzumab monotherapy is administered during maintenance phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone/Prednisolone/Methylprednisolone
2019
Completed Phase 4
~120
Vincristine
2003
Completed Phase 4
~2920
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin
2012
Completed Phase 3
~7940
Obinutuzumab
2015
Completed Phase 3
~3250
Bendamustine
2015
Completed Phase 3
~2950

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,018 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,446 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical exploration still accessible?

"According to clinicaltrials.gov, patient recruitment for this experiment has been concluded; the protocol was first posted on February 26th 2019 and last modified November 21st 2022. However, there are currently 3122 other trials requiring participants at present."

Answered by AI

Is this experiment the initial foray into its kind of research?

"At present, 1402 studies for Obinutuzumab are ongoing in 81 countries and 3024 cities. Alfacell's 1997 study was the earliest to include this drug; it involved 300 participants across its Phase 3 approval stages. In total, 2359 trials have been satisfactorily concluded since then."

Answered by AI

What are the more prevalent maladies that Obinutuzumab has been employed to address?

"Pheochromocytomas are typically treated with Obinutuzumab, a drug that is also able to help manage ulcerative colitis, varicella-zoster virus acute retinal necrosis and multiple myeloma."

Answered by AI

How many participants has this clinical trial recruited?

"This study is not currently seeking participants, as its last update was on November 21st 2022. If you are looking to join a clinical trial dealing with lymphoma or Obinutuzumab there are 1720 and 1402 trials respectively that need volunteers right now."

Answered by AI

Has Obinutuzumab been tested in prior medical investigations?

"Currently, there are 1,402 clinical trials centered around Obinutuzumab with 309 in the final phase of study. While Bethesda Maryland has a significant number of these studies underway, overall 53146 sites have participated in research surrounding this drug."

Answered by AI

What is the prevalence of hospitals administering this clinical test in the city?

"This trial is taking place at 12 different centers, including Center For Cancer and Blood Disorders in Bethesda, Texas Onc-Central Austin CA Ct in Austin, Rocky Mountain Cancer Center; Medical Oncology in Boulder and 9 other medical facilities."

Answered by AI

What potential risks might be associated with Obinutuzumab use?

"Due to the fact that Obinutuzumab is a Phase 4 treatment, meaning it has already been approved for public use, our team at Power rated its safety as 3."

Answered by AI
~19 spots leftby Mar 2025