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Alkylating agents

Ibrutinib + Rituximab 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
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
Previous documentation of biopsy-proven small lymphocytic lymphoma or diagnosis of CLL according to the NCI/IWCLL criteria with specific criteria met
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months
Awards & highlights

Study Summary

This trial is studying ibrutinib and rituximab compared to fludarabine phosphate, cyclophosphamide, and rituximab to see which works better in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?
This trial is for patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Participants should have symptoms like night sweats, weight loss, or anemia and meet specific blood criteria. They must not have had prior treatments for CLL/SLL, active infections, other primary cancers requiring treatment within 2 years, or certain heart conditions.Check my eligibility
What is being tested?
The study compares the effectiveness of Ibrutinib plus Rituximab against Fludarabine Phosphate with Cyclophosphamide and Rituximab in treating CLL/SLL. It aims to determine which combination works better at stopping cancer cell growth by either killing cells or helping the immune system attack them.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to cancer cells, such as fever and fatigue; digestive issues; increased risk of infection due to weakened immunity; possible liver function changes; and risks associated with taking capsules if there are pre-existing gastrointestinal conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with CLL or SLL.
Select...
I have a confirmed diagnosis of small lymphocytic lymphoma or CLL.
Select...
I am experiencing symptoms related to my disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months 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 (PFS) Rate at 3 Years
Secondary outcome measures
Overall Survival (OS) Rate at 3 Years
Progression-free Survival (PFS) by Measurable Residual Disease (MDR) Status at 2 Years
The Association Between Baseline Rai Stage and Complete Response (CR) Rate
+2 more
Other outcome measures
Association Between Single Nucleotide Polymorphisms (SNPs) and PFS
Collection of Relapse Samples
Distribution of Genetic Abnormalities Before and After Treatment
+3 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%
Nasopharyngitis
9%
Hyperuricaemia
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%
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
5%
Petechiae
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%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
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%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Abdominal distension
3%
Dry eye
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
3%
Osteoporosis
3%
Erythema
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%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
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%
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, rituximab)Experimental Treatment5 Interventions
Patients receive ibrutinib PO QD on days 1-28. Beginning cycle 2, patients also receive rituximab IV over 4 hours on days 1 and 2 of cycle 2, and day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
Group II: Arm B (rituximab, fludarabine phosphate, cyclophosphamide)Active Control6 Interventions
Patients receive rituximab IV over 4 hours on days 1 and 2 of cycle 1, and day 1 of cycles 2-6. Patients also receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,624 Total Patients Enrolled
Tait D ShanafeltPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
720 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02048813 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: Arm A (ibrutinib, rituximab), Arm B (rituximab, fludarabine phosphate, cyclophosphamide)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02048813 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02048813 — Phase 3

Frequently Asked Questions

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

Are we looking for more participants for this experiment?

"From what is available on clinicaltrials.gov, it seems as if this study has stopped looking for patients to participate. The original posting was on February 20th, 2014 with the most recent edit being on September 23rd, 2022. Even though this specific trial is no longer running, there are 4483 other trials that are still trying to recruit patients."

Answered by AI

Why is Ibrutinib prescribed?

"Ibrutinib is a medication that, while typically used to treat lung cancer, can also be used for b-cell lymphomas, polyangium, and multiple sclerosis."

Answered by AI

What are the aims of this research?

"The primary outcome of this study, which will be evaluated over a Baseline to 12 months after beginning therapy time frame is to Progression free survival (PFS). Secondary outcomes include Change in FACT-Leu TOI score, Overall survival (OS), and Impact of chronic lymphocytic leukemia (CLL) on QOL."

Answered by AI

What is the FDA's position on ibrutinib?

"Ibrutinib has been evaluated for safety in multiple Phase 3 trials, meaning that there is both efficacy and safety data available. Our team rates it as a 3 on our 1 to 3 scale."

Answered by AI

Is Ibrutinib a common medication in research trials?

"Ibrutinib is being studied in 1314 different clinical trials at the moment. Of those, 239 are in Phase 3. Although a majority of the trials for Ibrutinib are taking place in Philadelphia, Pennsylvania, there are 40806 locations running studies for this treatment across the globe."

Answered by AI

Does this experiment have an age limit of 85 years or younger?

"As this study's eligibility requirements indicate, the minimum age for participants is 18 while the maximum is 70."

Answered by AI

Can you tell me how many different research centers are participating in this project?

"There are 100 available for this trial. They are located at The Don and Sybil Harrington Cancer Center in Amarillo, Duly Health and Care Joliet in Joliet, New Ulm Medical Center in New Ulm, and many other places."

Answered by AI

How many people are currently taking part in this experiment?

"Unfortunately, this trial is not looking for new patients at the moment. Although, it's important to note that the study was last updated on September 23rd, 2022. If you're interested in other anemia trials or Ibrutinib trials, there are 3169 and 1314 studies recruiting respectively."

Answered by AI

May I apply to be a participant in this experiment?

"519 anemic patients between the ages of 18 and 70 who meet the following additional criteria are eligible for enrollment in this study: The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc), Fevers > 100.5 Fahrenheit (F) for 2 weeks without evidence of infection, Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly, Weight loss >="

Answered by AI

Who else is applying?

What site did they apply to?
Loyola University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

On second drug and no signs of improvement.
PatientReceived 2+ prior treatments
Recent research and studies
~47 spots leftby Apr 2025