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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
Must not have
Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
Active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10.75 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
Select...
I have chronic lymphocytic leukemia that has not been treated before.
Select...
My CLL condition requires treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not infected with HIV or HTLV-1.
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I haven't had a serious infection needing treatment in the last 2 months.
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I have an uncontrolled immune system disorder affecting my red blood cells or platelets.
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I need to take blood thinners like warfarin.
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I haven't used any experimental drugs or cancer treatments in the last 4 weeks.
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I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.
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I am currently pregnant or breastfeeding.
Select...
My CLL has transformed into a more aggressive form of lymphoma.
Select...
My health issues won't stop me from getting the trial's treatment, except for problems with my eyes, ears, nose, or throat.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have been diagnosed with progressive multifocal leukoencephalopathy.
Select...
My kidneys are not working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10.75 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10.75 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
Secondary study objectives
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
+12 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%
Headache
8%
Iron deficiency
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%
Oesophageal rupture
1%
Respiratory failure
1%
Compartment syndrome
1%
Invasive ductal breast carcinoma
1%
Colorectal cancer
1%
Malignant melanoma
1%
Non-small cell lung cancer
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Peripheral ischaemia
1%
Myelodysplastic syndrome
1%
Haemoptysis
1%
Pleural effusion
1%
Bronchopulmonary aspergillosis
1%
Cardiac failure congestive
1%
Gastritis
1%
Concussion
1%
Arthritis
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Ischaemic stroke
1%
Bacterial sepsis
1%
Leukopenia
1%
Acute myocardial infarction
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2014
Completed Phase 3
~3470
Chlorambucil
2002
Completed Phase 3
~3150
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,097,167 Total Patients Enrolled
AbbVieIndustry Sponsor
1,023 Previous Clinical Trials
519,844 Total Patients Enrolled
German CLL Study GroupOTHER
47 Previous Clinical Trials
18,936 Total Patients Enrolled

Media Library

Chlorambucil (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02242942 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: Safety Run-in Obinutuzumab + Venetoclax, Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Chronic Lymphocytic Leukemia Clinical Trial 2023: Chlorambucil Highlights & Side Effects. Trial Name: NCT02242942 — Phase 3
Chlorambucil (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02242942 — Phase 3
Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT02242942 — Phase 3
~41 spots leftby Nov 2025
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