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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have CLL/SLL and have not received any treatment yet.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • 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%
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%
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%
Actinic keratosis
5%
Dermatitis
5%
Gingival bleeding
5%
Stomatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
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%
Tinnitus
3%
Abdominal distension
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
3%
Inguinal hernia
3%
Rotator cuff syndrome
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%
Wheezing
1%
Wound infection staphylococcal
1%
Viral infection
1%
Cardiac failure acute
1%
Haemorrhagic disorder
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
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
~1890
Fludarabine
2012
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,843 Previous Clinical Trials
47,817,079 Total Patients Enrolled
41 Trials studying Lymphoma
7,996 Patients Enrolled for Lymphoma
Inhye Ahn, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
2 Previous Clinical Trials
118 Total Patients Enrolled
2 Trials studying Lymphoma
118 Patients Enrolled for Lymphoma
Andy Itsara, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Lymphoma
86 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have CLL/SLL and have not received any treatment yet.I can perform daily activities with minimal assistance.I understand the study's risks and can give informed consent.I do not have severe liver, kidney, or other life-threatening health issues.I have been diagnosed with CLL or SLL based on tissue analysis.I haven't had another cancer, serious gut issues, or a stroke recently.I am not currently on any immune, chemo, radio, or experimental therapies.I do not have active Hepatitis B, Hepatitis C, or HIV.I have symptoms like weight loss, fatigue, fevers, or swelling of lymph nodes.I am 18 or older, not allergic to study drugs, and don't need blood thinners like Coumadin.I have a history of CLL, autoimmune blood conditions, or bleeding disorders.I am not pregnant, breastfeeding, and am willing to use contraception.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib and short-course fludarabine
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathologies has Ibrutinib been found to remediate?
"Ibrutinib is an effective therapy for treating non-Hodgkin lymphoma, mantle cell lymphoma (MCL), and Waldenstrom macroglobulinemia."
Answered by AI
How many participants are being accepted for this medical research?
"This exact medical study is not accepting participants at this time, despite being initially posted on December 9th 2015 and last updated March 1st 2022. However, there are presently 2865 competing clinical trials for small lymphocytic lymphoma that have open recruitment slots and 518 studies involving Ibrutinib recruiting patients."
Answered by AI
What other researches have been done to explore the efficacy of Ibrutinib?
"At present, 518 studies dedicated to understanding Ibrutinib are underway. 43 of these live trials are in Phase 3 with Boston Massachusetts as the primary research hub for such investigations; however there is a global presence of 9984 trial sites across multiple continents."
Answered by AI
Are researchers still accepting participants for this clinical experiment?
"This medical study is no longer recruiting participants, having first been posted on December 9th 2015 and last updated on March 1st 2022. However, if you are looking for alternative trials then there are 2865 actively enrolling candidates with small lymphocytic lymphoma and 518 for Ibrutinib."
Answered by AI
What potential perils are associated with Ibrutinib intake?
"Since Ibrutinib is still in a Phase 2 trial, with some safety data but no efficacy information yet, it receives an estimated score of 2 on our scale."
Answered by AI
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