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Alkylating agents
Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia
Phase 3
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
Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
CLL requiring treatment according to IWCLL criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10.75 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for people with CLL and other medical conditions. The trial will last about a year, with follow-up for up to 9 years.
Who is the study for?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL) who have a life expectancy over 6 months and require treatment. They should not have severe other illnesses, must be able to use effective contraception, and cannot have central nervous system involvement or uncontrolled autoimmune conditions.Check my eligibility
What is being tested?
The study compares two treatments for CLL: Obinutuzumab combined with Venetoclax versus Obinutuzumab with Chlorambucil. It's an open-label, multicenter trial where participants are randomly assigned to either regimen for about one year, followed by up to nine years of follow-up.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used, liver problems, low blood counts leading to increased infection risk or bleeding issues. Side effects can vary based on individual health conditions and drug interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic lymphocytic leukemia that has not been treated before.
Select...
My CLL condition requires treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 10.75 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10.75 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 (PFS) Based on Investigator Assessment According to IWCLL Criteria
Secondary outcome measures
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
+19 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%
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%
Acute myocardial infarction
1%
Haemoptysis
1%
Arthritis
1%
Colorectal cancer
1%
Uterine prolapse
1%
Compartment syndrome
1%
Leukopenia
1%
Bronchitis chronic
1%
Myelodysplastic syndrome
1%
Non-small cell lung cancer
1%
Bronchopulmonary aspergillosis
1%
Concussion
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Malignant melanoma
1%
Respiratory failure
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Invasive ductal breast carcinoma
1%
Ischaemic stroke
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
Group I: Safety Run-in Obinutuzumab + VenetoclaxExperimental Treatment2 Interventions
Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
Group II: Obinutuzumab + VenetoclaxExperimental Treatment2 Interventions
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Group III: Obinutuzumab + ChlorambucilExperimental Treatment2 Interventions
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Chlorambucil
2002
Completed Phase 3
~3750
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,441 Total Patients Enrolled
AbbVieIndustry Sponsor
962 Previous Clinical Trials
502,668 Total Patients Enrolled
German CLL Study GroupOTHER
47 Previous Clinical Trials
18,910 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not infected with HIV or HTLV-1.I haven't had a serious infection needing treatment in the last 2 months.I have chronic lymphocytic leukemia that has not been treated before.I have an uncontrolled immune system disorder affecting my red blood cells or platelets.I had cancer before but have recovered from the treatment side effects.My blood cell counts are good without needing extra help, unless it's because of my CLL.I need to take blood thinners like warfarin.I haven't used any experimental drugs or cancer treatments in the last 4 weeks.My CLL condition requires treatment.I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.I am currently pregnant or breastfeeding.My CLL has transformed into a more aggressive form of lymphoma.My health issues won't stop me from getting the trial's treatment, except for problems with my eyes, ears, nose, or throat.My cancer has spread to my brain or spinal cord.I have been diagnosed with progressive multifocal leukoencephalopathy.My liver is working well.My kidneys are not working well.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab + Chlorambucil
- Group 2: Safety Run-in Obinutuzumab + Venetoclax
- Group 3: Obinutuzumab + Venetoclax
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT02242942 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Obinutuzumab been investigated in other research?
"There are currently 295 Obinutuzumab trials underway, with 39 in Phase 3. While Edmonton, Alberta has a high density of Obinutuzumab clinical trials, there are 8856 total locations for these trials."
Answered by AI
Could you please outline the potential dangers of Obinutuzumab?
"Obinutuzumab has received a score of 3 for safety. This is because it is a Phase 3 trial, and thus there is some data demonstrating its efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
Obinutuzumab is most commonly used to treat what condition?
"While obinutuzumab is most commonly used as a lymphoma treatment, it can also be taken to help manage other conditions like mantle cell lymphoma (mcl), small lymphocytic lymphoma, and indolent lymphoma."
Answered by AI
Is it possible to sign up for the clinical trial at this time?
"This particular clinical trial, as noted on clinicaltrials.gov, is not recruiting patients at the moment. The study was first posted on December 31st, 2014 but was last updated on September 28th, 2022. Although this study is not looking for candidates, there are 1864 other trials that are."
Answered by AI
How many people have been asked to participate in this trial thus far?
"Unfortunately, this clinical trial is not presently enrolling patients. The study was posted December 31st, 2014 and was last updated September 28th, 2022. However, there are 1569 other trials for leukemia and 295 trials for Obinutuzumab enrolling patients right now."
Answered by AI
What is unique about this clinical trial in comparison to others?
"As of now, there are 295 active Obinutuzumab clinical trials in 1362 cities and 52 countries. The very first one was completed in 2012 by Janssen Research & Development, LLC. That initial trial had 232 patients and finished Phase 3 drug approval. In the 8 years since then, there have been 113 more trials."
Answered by AI
How many locations are conducting this experiment?
"To limit the amount of travelling required from potential participants, this trial is currently recruiting patients from 12 sites that are located in cities such as Atlanta, Harvey and Detroit."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Ingalls Memorial Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
Why did patients apply to this trial?
I have CLL and haven't had treatment since 5/22.
PatientReceived 1 prior treatment
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