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Alkylating agents
Ibrutinib + FCR for Chronic Lymphocytic Leukemia (iFCR Trial)
Phase 2
Waitlist Available
Led By Matthew Davids, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per IW-CLL 2008 criteria. Patients must also require therapy for that diagnosis, based on meeting at least one of the following criteria: evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <11.0 g/L) and/or thrombocytopenia (platelets <100 x 10^9/L); massive (≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly; massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of <6 months. Lymphocyte doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of <30 x 10^9/L, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded; autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy; documented constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs: unintentional weight loss >10% within 6 months prior to screening; significant fatigue (inability to work or perform usual activities); fevers >100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection; night sweats for more than 1 month prior to screening without evidence of infection; no prior CLL-directed therapy that was instituted due to patient previously meeting IW-CLL 2008 criteria for treatment; age greater than or equal to 18 years and less than or equal to 65. Because CLL is extremely rare in persons <18 years of age, children are excluded from this study. Because iFCR is an aggressive therapy that is likely to be less well-tolerated even in fit elderly subjects, persons > 65 years of age are excluded; ECOG performance status ≤ 1; adequate hematologic function independent of growth factor support for at least 7 days prior to screening and randomization, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which cannot be administered within 14 days of screening; patients must meet the following hematologic criteria at screening: absolute neutrophil count ≥ 750 cells/mm3 (0.75 x 109/L); platelet count ≥ 50,000 cells/mm3 (50 x 109/L); hemoglobin ≥ 8 g/L; adequate hepatic and renal function defined as: serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN); bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); adequate renal function defined by serum creatinine >1.5 x ULN; PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN; the effects of ibrutinib on the developing human fetus are unknown. For this reason and because similar agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
significant fatigue (inability to work or perform usual activities)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
iFCR Trial Summary
This trial is testing ibrutinib in combo with FCR as a possible treatment for CLL.
Who is the study for?
Adults aged 18-65 with confirmed chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment based on specific criteria like worsening anemia, significant weight loss, fatigue, fevers without infection, and night sweats. They should not have had previous CLL therapy and must be able to perform daily activities (ECOG ≤1). Adequate blood counts and liver/renal function are required. Participants must use effective contraception.Check my eligibility
What is being tested?
The trial is testing a new drug combination for treating Chronic Lymphocytic Leukemia (CLL). It involves adding the drug Ibrutinib to the standard FCR regimen (Fludarabine, Cyclophosphamide, Rituximab) to see if it improves outcomes in younger patients who haven't been treated before.See study design
What are the potential side effects?
Possible side effects include diarrhea, bleeding problems due to low platelets, infections from low white blood cell count, fatigue from anemia or the drugs themselves. Liver issues might arise shown by abnormal blood tests. Allergic reactions during infusion of Rituximab can also occur.
iFCR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am too tired to work or do my usual activities.
Select...
I have lost more than 10% of my weight without trying in the last 6 months.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My kidney function is within normal limits based on my creatinine levels.
Select...
I have not received treatment for CLL based on specific criteria.
Select...
I have had night sweats for over a month without being sick.
Select...
I have had fevers over 100.5°F or 38.0°C for more than 2 weeks without signs of infection.
Select...
My blood tests show worsening anemia or low platelets.
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Select...
I have very large or worsening swollen lymph nodes.
Select...
My spleen is very large, getting bigger, or causing symptoms.
iFCR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part I: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Months Post FCR
Part II: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Years Post Discontinuation of Ibrutinib After Having Achieved MRD Negative CR at the 2 Months Post FCR Timepoint
Secondary outcome measures
1-year Combined Response With MRD From Bone Marrow
Complete Response Rate (CRR)
Median Overall Survival (OS)
+8 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%
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
iFCR Trial Design
1Treatment groups
Experimental Treatment
Group I: IbrutinibExperimental Treatment4 Interventions
- Ibrutinib-
Oral, daily during each cycle
fludarabine-administered at standard dosing for up to 6 cycles
cyclophosphamide-administered at standard dosing for up to 6 cycles
rituximab-administered at standard dosing for up to 6 cycles
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
Cyclophosphamide
1995
Completed Phase 3
~3770
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,730 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,046 Total Patients Enrolled
Blood Cancer Research PartnershipOTHER
4 Previous Clinical Trials
146 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am too tired to work or do my usual activities.I have not received any live vaccines in the last 4 weeks.I am not on warfarin or vitamin K antagonists for blood thinning.I am on preventive antibiotics with no active infection and my medication is not prohibited.I have had cancer before, but it was a different type than my current diagnosis.I have not had a stroke or brain bleed in the last 6 months.I do not have any ongoing infections that aren’t being treated.I cannot take pills due to issues with my stomach or intestines.I am not taking strong CYP3A inhibitors or inducers.My cancer has spread to my brain.My liver and kidney functions are within normal ranges.I need treatment for my diagnosis.I have lost more than 10% of my weight without trying in the last 6 months.I have HIV or active hepatitis but meet the specific testing requirements for enrollment.I am fully active and can carry on all my pre-disease activities without restriction.My leukemia has an unmutated IGHV and complex genetic changes.My lymphocyte levels have rapidly increased, not due to infection.My kidney function is within normal limits based on my creatinine levels.My blood counts are stable without needing frequent medication to boost them.I have not received treatment for CLL based on specific criteria.I finished treatment for an infection less than 14 days ago.I have had night sweats for over a month without being sick.I have not had major surgery in the last 4 weeks.I have had fevers over 100.5°F or 38.0°C for more than 2 weeks without signs of infection.My tests show a specific genetic change in at least 20% of my cells.I agree to use effective birth control during the study.My early-stage cancer was treated successfully with no signs of disease.I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.My blood tests show worsening anemia or low platelets.I am between 18 and 65 years old.I had skin cancer (not melanoma) treated and currently show no signs of it.I have a bleeding disorder such as von Willebrand's disease or hemophilia.I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.I have very large or worsening swollen lymph nodes.My cancer was treated with the goal of cure, and I've been cancer-free for over 3 years.I do not have serious heart problems or recent heart attacks.I cannot take preventive treatment for pneumocystis.My spleen is very large, getting bigger, or causing symptoms.I have symptoms related to my disease.My blood condition doesn't improve with standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Ibrutinib
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.
Which type of person do you think would be better suited for this research project?
"The ideal candidate for this clinical trial would be diagnosed with leukemia, between 18-65 years old. So far, 85 patients have been recruited."
Answered by AI
Why did researchers start this clinical trial in the first place?
"The purpose of this study, as stated by the sponsor Pharmacyclics LLC., is to assess the efficacy of ibrutinib in combination with FCR in achieving minimal residual disease negative complete response in patients with CLL. This will be measured over a 2 year period after discontinuation of ibrutinib and 24 months of ibrutinib maintenance interval. In addition to the primary outcome, the trial will also evaluate secondary outcomes including rate of MRD negative CR after 1 year of ibrutinib+FCR and 3 cycles of iFCR, as well as rates of complete response."
Answered by AI
How many people are currently signed up to participate in this trial?
"This particular trial is not recruiting patients at this time. The listing was first created on October 1st, 2014 and updated September 28th, 2022. If the participant is looking for other trials, there are 1577 clinical trials actively searching for participants with leukemia and 1314 trials for Ibrutinib enrolling patients right now."
Answered by AI
What are the conditions that ibrutinib has been shown to be effective against?
"Ibrutinib is a medication that oncologists frequently prescribe to patients with lung cancer. Additionally, ibrutinib has shown efficacy in treating b-cell lymphomas, multiple sclerosis, and polyangium."
Answered by AI
What similar studies has Ibrutinib been a part of in the past?
"Ibrutinib was first studied in 1993 at National Institutes of Health Clinical Center. There have been a total of 1929 completed trials since then, with 1314 live studies as of now. Many of these active studies are based out of Coral Gables, Massachusetts."
Answered by AI
In how many different geographic areas is this trial taking place?
"This study is enrolling patients at 9 sites across the United States of America. A few notable locations include Coral Gables, Boston and Deerfield Beach. To try and limit participant burden, it is best to select a trial site that is closest to your home."
Answered by AI
Does Ibrutinib have any severe side effects?
"While ibrutinib has yet to demonstrate efficacy in clinical trials, it has received a score of 2 for safety."
Answered by AI
Do patients have to be a certain age to qualify for this experimental treatment?
"For this particular study, only patients between 18-65 years old can enroll. However, there are 810 other clinical trials that cater to individuals under 18 and 2340 for seniors above 65."
Answered by AI
Are people still signing up for this experiment?
"Unfortunately, this particular clinical trial is not taking any more patients at the moment. The original posting date was October 1st, 2014, with the latest edit on September 28th, 2022. However, there are still many other studies that need participants. For example, there are 1577 trials for leukemia and 1314 for Ibrutinib currently looking for patients to enroll."
Answered by AI
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