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Anti-metabolites

Ibrutinib + Fludarabine for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Inhye Ahn, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment naive CLL/SLL patients with specific criteria for treatment-naive status
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Must not have
Major surgery within specific timeframe, currently active, clinically significant cardiovascular disease, subjects who received or require strong CYP3A inhibitors
Impaired hepatic function, impaired renal function, life-threatening illness, medical condition or organ system dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combination of ibrutinib and fludarabine for people with CLL who have not had treatment before. The trial will measure how well the combination works and how safe it is.

Who is the study for?
This trial is for adults with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have certain blood cell counts and are able to perform daily activities. They must not have had previous CLL treatments, be free from significant heart disease, active infections like Hepatitis B/C or HIV, and agree to use effective contraception.
What is being tested?
The study tests the combination of Ibrutinib taken daily until disease progression or side effects become intolerable, with Fludarabine given in short courses. The main goals are to see how many patients achieve a complete response after 6 cycles and monitor those who stop treatment due to side effects within the same period.
What are the potential side effects?
Potential side effects include diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain from Ibrutinib; while Fludarabine may cause immune system suppression leading to increased infection risk, nausea, fatigue and potential lung toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have CLL/SLL and have not received any treatment yet.
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I can perform daily activities with minimal assistance.
Select...
I understand the study's risks and can give informed consent.
Select...
I have been diagnosed with CLL or SLL based on tissue analysis.
Select...
I have symptoms like weight loss, fatigue, fevers, or swelling of lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe liver, kidney, or other life-threatening health issues.
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I am not currently on any immune, chemo, radio, or experimental therapies.
Select...
I do not have active Hepatitis B, Hepatitis C, or HIV.
Select...
I haven't had another cancer, serious gut issues, or a stroke recently.
Select...
I am 18 or older, not allergic to study drugs, and don't need blood thinners like Coumadin.
Select...
I have a history of CLL, autoimmune blood conditions, or bleeding disorders.
Select...
I am not pregnant, breastfeeding, and am willing to use contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Complete Response at 24 Weeks
Rate of Treatment Discontinuation Within the First 24 Weeks

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%
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%
Chest pain
5%
Gingival bleeding
5%
Mouth ulceration
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%
Tinnitus
3%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Dysphagia
3%
Dry eye
3%
Dysuria
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%
Stress fracture
1%
Lumbar vertebral 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

1Treatment groups
Experimental Treatment
Group I: Ibrutinib and short-course fludarabineExperimental Treatment2 Interventions
* Ibrutinib 420 mg PO daily for the duration of the study * Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,934 Previous Clinical Trials
47,792,247 Total Patients Enrolled
Inhye Ahn, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
2 Previous Clinical Trials
118 Total Patients Enrolled
Andy Itsara, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Fludarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02514083 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Ibrutinib and short-course fludarabine
Chronic Lymphocytic Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT02514083 — Phase 2
Fludarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02514083 — Phase 2
~3 spots leftby Nov 2025
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