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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib +/− Rituximab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Jan A Burger
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must be age >= 18 years at the time of signing informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations
Must not have
Treatment including chemotherapy, chemo-immunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (more than 60 mg prednisone daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment date, anticipation of need for major surgical procedure during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying ibrutinib with or without rituximab to see which is more effective in treating patients with chronic lymphocytic leukemia that has come back after treatment.
Who is the study for?
This trial is for adults over 18 with relapsed chronic lymphocytic leukemia who need treatment. They must be willing to use effective birth control and have no major health issues or recent treatments that could interfere. People with certain heart diseases, uncontrolled infections, bleeding disorders, or those pregnant/breastfeeding can't join.
What is being tested?
The study is testing the effectiveness of Ibrutinib alone versus combined with Rituximab in patients whose chronic lymphocytic leukemia has returned after treatment. It aims to see if adding an immunotherapy agent (Rituximab) improves outcomes compared to just using a cell growth blocker (Ibrutinib).
What are the potential side effects?
Possible side effects include diarrhea, muscle pain, fever, fatigue and rash from Ibrutinib; Rituximab may cause infusion reactions like chills and fevers as well as increase infection risk due to immune system changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 or older, understand and agree to the study's consent, and can follow the study procedures.
Select...
I agree to use effective birth control during and 30 days after the study.
Select...
I am recommended for treatment based on specific leukemia guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer treatments like chemotherapy or immunotherapy in the last 21 days.
Select...
I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.
Select...
I do not have an ongoing infection that isn't getting better with treatment.
Select...
I do not have uncontrolled autoimmune blood disorders.
Select...
I do not have severe diseases or organ problems that make treatment risky.
Select...
I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.
Select...
My blood tests show very low white blood cells or platelets not due to my condition.
Select...
I have a serious wound or fracture that is not healing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 rate
Secondary study objectives
Changes in immune parameters (lymphocyte subpopulations, immunoglobulin levels)
Estimated progression-free survival
Incidence of adverse events
+2 moreSide effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
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%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Insomnia
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dyspepsia
7%
Dry skin
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
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%
Abdominal discomfort
5%
Gingival bleeding
5%
Mouth ulceration
5%
Chest pain
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
5%
Petechiae
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%
Retinal haemorrhage
4%
Angina pectoris
4%
Dry mouth
4%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
4%
Sepsis
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%
Abdominal distension
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Tinnitus
3%
Dysphagia
3%
Dry eye
3%
Dysuria
3%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Pollakiuria
3%
Hypoalbuminaemia
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
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%
Pleural effusion
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Post procedural haemorrhage
1%
Laryngeal oedema
1%
Lumbar vertebral fracture
1%
Stress fracture
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Wheezing
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%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary 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%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (ibrutinib, rituximab)Experimental Treatment4 Interventions
Patients receive ibrutinib as in Arm I beginning on day 1 or 2. Patients also receive rituximab IV over 3-8 hours on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2-6. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (ibrutinib)Experimental Treatment3 Interventions
Patients receive ibrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Ibrutinib
2014
Completed Phase 4
~2060
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,104 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,742 Total Patients Enrolled
Jan A BurgerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatments like chemotherapy or immunotherapy in the last 21 days.I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.I do not have an ongoing infection that isn't getting better with treatment.I do not have uncontrolled autoimmune blood disorders.I do not have severe diseases or organ problems that make treatment risky.I have not had a stroke or brain bleed in the last 6 months.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I agree to use effective birth control during and 30 days after the study.I haven't had cancer (except certain skin, cervix, or breast cancers) in the last 3 years.I can take care of myself and am up and about more than half of my waking hours.I am 18 or older, understand and agree to the study's consent, and can follow the study procedures.I have not had bleeding or clotting problems in the last 3 months.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I am recommended for treatment based on specific leukemia guidelines.My blood tests show very low white blood cells or platelets not due to my condition.I have a serious wound or fracture that is not healing.I have not had minor surgery or needle biopsies in the last week, except for bone marrow procedures.I have not taken Coumadin in the last 7 days.I have been treated with ibrutinib or similar drugs but not with Zydelig.I have CLL/SLL/PLL, treated before or untreated with specific genetic changes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ibrutinib)
- Group 2: Arm II (ibrutinib, rituximab)
Awards:
This trial has 1 awards, including:- 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.