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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
Must not have
Specific gastrointestinal conditions
Currently active hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months
Awards & highlights

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.
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.
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
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I have been diagnosed with CLL or SLL.
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I have a confirmed diagnosis of small lymphocytic lymphoma or CLL.
Select...
I am experiencing symptoms related to my disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a specific condition affecting my digestive system.
Select...
I have liver problems right now.
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I have a bleeding disorder or hemophilia.
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I do not have recent heart issues, infections, strokes, active hepatitis, or abnormal lab results.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS) Rate at 3 Years
Secondary study objectives
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 study objectives
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%
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%
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%
Gingival bleeding
5%
Mouth ulceration
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
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%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Dysuria
3%
Tinnitus
3%
Rotator cuff syndrome
3%
Pollakiuria
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
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%
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%
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 4
~2020
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,471 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
~46 spots leftby Sep 2025
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