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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
Must not have
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drugs and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
Requires treatment with a strong cytochrome P450 (CYP), family 3, subfamily A (3A) inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself but might not be able to do heavy physical work.
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I have CLL/SLL with a specific gene mutation and need first-line treatment.
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I have not had any treatment for CLL before.
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My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major treatments or experimental therapy for my condition in the last 3 to 6 weeks.
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I need treatment with a strong medication that affects liver enzymes.
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I have a bleeding disorder like von Willebrand's disease or hemophilia.
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I do not have serious heart conditions like recent heart attacks or uncontrolled heart rhythm problems.
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I cannot take medications by mouth due to a digestive condition.
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I am currently taking warfarin or similar blood thinners.
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My cancer has a specific genetic feature (unmutated IGHV).
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I have an active autoimmune condition needing steroids.
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My cancer has a specific genetic change known as del(17p) or TP53 mutation.
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I do not have an untreated or uncontrolled infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 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%
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%
Bladder transitional cell carcinoma
3%
Abdominal distension
3%
Tinnitus
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: Treatment (iFCG)Experimental Treatment4 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Ibrutinib
2014
Completed Phase 4
~2060
Obinutuzumab
2014
Completed Phase 3
~3470

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,164 Total Patients Enrolled
Nitin JainPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
508 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02629809 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (iFCG)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02629809 — Phase 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02629809 — Phase 2
~3 spots leftby Mar 2025
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