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Alkylating Agent
Combination Therapy for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Nitin Jain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients with a diagnosis of CLL/small lymphocytic lymphoma (SLL), with mutated (> 2% deviation from germ line) IGHV gene, who meet criteria to initiate first-line treatment per International Workshop on CLL Working Group (IWCLL) 2008 guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat chronic lymphocytic leukemia. Ibrutinib may stop cancer cell growth by blocking enzymes needed for cell growth. Fludarabine phosphate and cyclophosphamide work in different ways to stop cancer cell growth. Obinutuzumab may interfere with the ability of tumor cells to grow and spread. The combination of these drugs may work better to treat chronic lymphocytic leukemia.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia who haven't had previous CLL treatments, have a certain type of gene mutation (mutated IGHV), and are in good physical condition (ECOG <=2). They must not be pregnant or breastfeeding, agree to use effective contraception, and cannot have other serious health issues like significant heart disease, uncontrolled infections, or bleeding disorders.Check my eligibility
What is being tested?
The study tests a combination of the drug ibrutinib with chemotherapy drugs fludarabine phosphate and cyclophosphamide plus the monoclonal antibody obinutuzumab. The goal is to see if this mix can better stop cancer cells from growing compared to current treatments by using both targeted therapy and immune system activation.See study design
What are the potential side effects?
Possible side effects include diarrhea, fatigue, muscle pain, nausea; low blood cell counts leading to increased infection risk; liver problems; allergic reactions; bleeding complications due to platelet reduction. Some may experience more severe immune-related effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have CLL/SLL with a specific gene mutation and need first-line treatment.
Select...
I have not had any treatment for CLL before.
Select...
My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the combination of ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab defined as achievement of complete remission/complete remission with incomplete marrow recovery and bone marrow minimal residual disease-negative status
Secondary outcome measures
Bone marrow minimal residual disease-negative status
Incidence of treatment emergent toxicities using a Bayesian design by Thall, Simon and Estey assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Long-term incidence rate of Richter's transformation
+4 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%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Nasopharyngitis
9%
Hyperuricaemia
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
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%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Abdominal distension
3%
Dry eye
3%
Bladder transitional cell carcinoma
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
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%
Wheezing
1%
Viral infection
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
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: Treatment (iFCG)Experimental Treatment4 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,700 Total Patients Enrolled
Nitin JainPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
508 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major treatments or experimental therapy for my condition in the last 3 to 6 weeks.I need treatment with a strong medication that affects liver enzymes.I have a bleeding disorder like von Willebrand's disease or hemophilia.I can take care of myself but might not be able to do heavy physical work.I do not have serious heart conditions like recent heart attacks or uncontrolled heart rhythm problems.I haven't had cancer (except certain skin, cervix, or breast cancers) in the last 3 years.I cannot take medications by mouth due to a digestive condition.I am currently taking warfarin or similar blood thinners.I have CLL/SLL with a specific gene mutation and need first-line treatment.I am not pregnant, will use birth control during the study, and for 30 days after.My cancer has a specific genetic feature (unmutated IGHV).I do not have active hepatitis B or C, and I am not HIV positive.I have an active autoimmune condition needing steroids.My cancer has a specific genetic change known as del(17p) or TP53 mutation.I have not had a stroke or brain bleed in the last 6 months.I do not have an untreated or uncontrolled infection.I am not currently receiving chemotherapy, radiotherapy, or immunotherapy.I have not had any treatment for CLL before.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (iFCG)
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 potential risks have been associated with the use of Ibrutinib?
"Taking into consideration the stage of this research, the safety level of Ibrutinib was determined to be a 2. This is due to some existing data suggesting its security but no evidence for efficacy."
Answered by AI
What is Ibrutinib regularly prescribed to treat?
"Ibrutinib is typically administered to manage multiple sclerosis, but can also be deployed in the management of acute myelocytic leukemia, retinoblastoma, and histiocytic lymphoma."
Answered by AI
How many participants are enrolled in this experiment?
"At the moment, this clinical trial is not recruiting participants. It was initially advertised on March 18th 2016 and has been amended most recently on August 18th 2022. If you're looking for alternative studies, there are 1520 ongoing trials involving leukaemia, lymphocytic chronic B-cell related illnesses that accept patients as well as 1102 Ibrutinib based investigations accepting enrolments."
Answered by AI
Are there other precedents for the usage of Ibrutinib in clinical research?
"Presently, there are 1102 active clinical trials for Ibrutinib with 190 of those in Phase 3. Philadelphia Pennsylvania is the primary site conducting these studies, however many other locations have also joined this effort and 36458 sites can now be found researching Ibrutinib."
Answered by AI
Are additional volunteers being recruited for this medical experiment?
"As of August 18th 2022, this clinical trial is no longer accepting participants. Initially posted on March 18th 2016, it has been concluded and archived. Fortunately for those seeking to participate in trials related to leukemia, lymphocytic, chronic b-cell or Ibrutinib research there are 1520 and 1102 active studies respectively."
Answered by AI
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