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Kinase Inhibitor

Combination Therapy for Chronic Lymphocytic Leukemia

Phase 3
Waitlist Available
Led By Tait D Shanafelt
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
No current use of corticosteroids except for low doses for non-hematologic conditions
No other active primary malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is studying ibrutinib, obinutuzumab, and venetoclax to treat patients with chronic lymphocytic leukemia.

Who is the study for?
Adults aged 18-70 with chronic lymphocytic leukemia who haven't had prior CLL treatments, have progressive symptoms or blood abnormalities, and meet specific health criteria. They must not be pregnant/breastfeeding, have certain heart conditions or infections, take strong CYP3A inhibitors/inducers, or have other active cancers.Check my eligibility
What is being tested?
The trial is testing if adding Venetoclax to Ibrutinib and Obinutuzumab treatment provides better outcomes for chronic lymphocytic leukemia patients than just Ibrutinib and Obinutuzumab. It includes biospecimen collection, CT scans, bone marrow biopsies, and quality-of-life assessments.See study design
What are the potential side effects?
Possible side effects include diarrhea, nausea, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; muscle and bone pain; rash; fever; coughing; shortness of breath. Some may experience liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently using corticosteroids, or only using low doses for non-blood related conditions.
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I do not have any other active cancer besides the one being treated.
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I have been diagnosed with CLL or SLL.
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I haven't received specific drug treatments for my CLL or SLL.
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My stomach and intestines work normally.
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I am between 18 and 70 years old.
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I do not have an active blood disorder that destroys red blood cells and requires treatment to suppress my immune system.
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I haven't needed high dose steroids for autoimmune issues.
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I can swallow pills.
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I have worsening bone marrow failure or symptoms due to enlarged lymph nodes, spleen, or liver.
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I am able to get out of my bed or chair and move around.
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My kidney function is good, with a GFR over 40 mL/min.
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My genetic test shows no deletion on chromosome 17.
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My blood cancer type matches CLL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Progression-free survival
Secondary outcome measures
Incidence of adverse events
Overall survival
Other outcome measures
Adherence
FACT-Leu Trial Outcome Index (TOI) score over time
Minimal residual disease (MRD) analysis
+1 more

Side effects data

From 2022 Phase 3 trial • 201 Patients • NCT03053440
37%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Hyperuricaemia
9%
Nasopharyngitis
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Conjunctival haemorrhage
6%
Cataract
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Dermatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Ecchymosis
4%
Haemorrhoids
4%
Vertigo
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Erythema
3%
Osteoporosis
3%
Dysuria
3%
Rotator cuff syndrome
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Hypoalbuminaemia
3%
Pollakiuria
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Haemolytic anaemia
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Haemorrhagic disorder
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (ibrutinib, obinutuzumab, venetoclax)Experimental Treatment7 Interventions
Patients receive ibrutinib PO daily on days 1-28 and obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 1-28 of cycles 3-14. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.
Group II: Arm B (ibrutinib, obinutuzumab)Active Control6 Interventions
Patients receive ibrutinib PO and obinutuzumab as in arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,607 Previous Clinical Trials
40,913,442 Total Patients Enrolled
Tait D ShanafeltPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
529 Total Patients Enrolled

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03701282 — Phase 3
Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03701282 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: Arm A (ibrutinib, obinutuzumab, venetoclax), Arm B (ibrutinib, obinutuzumab)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT03701282 — Phase 3
Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT03701282 — Phase 3

Frequently Asked Questions

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

Are there specific qualifying criteria for participants of this research?

"The requirements for this study are that the potential patient has a chronic lymphocytic leukemia diagnosis and is between 18-69 years old. Up to 720 people will be accepted into the trial."

Answered by AI

Is this a full trial or are there still opportunities for volunteers?

"Unfortunately, this particular clinical trial is no longer actively recruiting participants. The study was initially posted on 1/3/2019 but the most recent update occurred on 10/18/2022. If you are looking for other studies, there are presently 1575 clinical trials actively recruiting participants with chronic lymphocytic leukemia (cll) and 412 studies for Ibrutinib actively recruiting patients."

Answered by AI

What is the Ibrutinib success rate in medical trials?

"Ibrutinib's safety was rated a 3 by our Power team. This is because ibrutinib has undergone Phase 3 trials, gathering data to support efficacy as well as multiple rounds of tests affirming its safety."

Answered by AI

Is this a widespread trial in the United States?

"Salina Regional Health Center in Salina, Kansas, Franciscan Health Mooresville in Mooresville, Michigan, and Beaumont Hospital - Dearborn in Dearborn, South carolina are all enrolling patients for this trial. In addition, there are 100 other locations that are also participating."

Answered by AI

What is the current patient sample size for this research project?

"This study is not recruiting at this moment. The trial was first posted on 1/3/2019 and updated for the last time on 10/18/2022. However, there are 1575 other trials actively recruiting patients with chronic lymphocytic leukemia (CLL) and 412 Ibrutinib trials that may be of interest."

Answered by AI

Are individuals older than 25 years of age able to participate in this research?

"The parameters for inclusion in this particular trial are that applicants must be aged 18 to 69. There are 478 trials currently searching for patients under the age of 18 and 1670 for elderly patients."

Answered by AI

What are the most similar Ibrutinib trials that have been completed?

"The original ibrutinib study took place in 2011 at the National Institutes of Health Clinical Center. To date, there have been a total of 308 completed clinical trials worldwide. As of right now, 412 active trials are taking place; many of these in Salina, Kansas."

Answered by AI

For what purposes is Ibrutinib most commonly given to patients?

"Ibrutinib is often used to treat small lymphocytic lymphoma. It can also help patients with conditions like lymphoid leukemia, waldenstrom macroglobulinemia, and refractory follicular lymphoma by reducing the activity of certain enzymes."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
West Virginia
How old are they?
65+
What site did they apply to?
Loyola University Medical Center
Western Maryland Regional Medical Center
Geisinger Wyoming Valley/Henry Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

What questions have other patients asked about this trial?

Am I taking the best medication that comes with no side effects to fight CLL?
PatientReceived no prior treatments

Why did patients apply to this trial?

I was on Imbruvica for 14 months but BCBS is no longer covering it. Imbruvica is what I was started on after several dose changes I could not tolerate the medication and was changed to Brukinsa which has no side effects after taking for 2 months.
PatientReceived 1 prior treatment
~321 spots leftby May 2028