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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)
Must not have
Any uncontrolled active systemic infection.
Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am too tired to work or do my usual activities.
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I have lost more than 10% of my weight without trying in the last 6 months.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My kidney function is within normal limits based on my creatinine levels.
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I have not received treatment for CLL based on specific criteria.
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I have had night sweats for over a month without being sick.
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I have had fevers over 100.5°F or 38.0°C for more than 2 weeks without signs of infection.
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My blood tests show worsening anemia or low platelets.
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I am between 18 and 65 years old.
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I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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I have very large or worsening swollen lymph nodes.
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My spleen is very large, getting bigger, or causing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing infections that aren’t being treated.
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I cannot take pills due to issues with my stomach or intestines.
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I am not taking strong CYP3A inhibitors or inducers.
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My cancer has spread to my brain.
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I have HIV or active hepatitis but meet the specific testing requirements for enrollment.
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My leukemia has an unmutated IGHV and complex genetic changes.
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I have not had major surgery in the last 4 weeks.
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My tests show a specific genetic change in at least 20% of my cells.
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My early-stage cancer was treated successfully with no signs of disease.
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I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.
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I had skin cancer (not melanoma) treated and currently show no signs of it.
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I have a bleeding disorder such as von Willebrand's disease or hemophilia.
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I cannot take preventive treatment for pneumocystis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
1-year Combined Response With MRD From Bone Marrow
Complete Response Rate (CRR)
Median Overall Survival (OS)
+8 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

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
~2020
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,723 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
85 Previous Clinical Trials
26,209 Total Patients Enrolled
Blood Cancer Research PartnershipOTHER
4 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02251548 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Ibrutinib
Chronic Lymphocytic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02251548 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02251548 — Phase 2
~2 spots leftby Jan 2025
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