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PI3K Inhibitor
Intermittent Duvelisib for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Alexey V Danilov
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of duvelisib until time of duvelisib discontinuation up to 5 years.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing how well duvelisib works on an irregular schedule to treat CLL or SLL. Duvelisib may stop cancer cell growth by blocking some enzymes needed for cell growth. Giving duvelisib on an irregular schedule may reduce severe side effects.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who've had at least one prior treatment and need more because their disease has progressed or hasn't improved. They must be able to take pills, have decent organ function, and not be pregnant or breastfeeding. People can't join if they've recently used certain drugs, have uncontrolled other diseases, are on high-dose steroids, or have a history of severe heart problems.
What is being tested?
The trial is testing the effectiveness of Duvelisib given intermittently in patients with specific types of blood cancer. Researchers want to see if taking this drug irregularly might control the cancer while causing fewer serious side effects compared to regular dosing schedules.
What are the potential side effects?
Duvelisib may cause diarrhea, fever, fatigue, rash, coughing and shortness of breath among other symptoms. It can also affect liver enzymes and blood counts which could lead to increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of duvelisib until time of duvelisib discontinuation up to 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of duvelisib until time of duvelisib discontinuation up to 5 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS) at 12 Months
Secondary study objectives
Median Progression-Free Survival (PFS)
Number of Administrated Cycles of the Study Treatment
Objective Response Rate (ORR) (Including Complete Response [CR] and Partial Response [PR])
+2 moreOther study objectives
Percent distribution of circulating T-cells within duvelisib-treated CLL patients
Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452250%
Diarrhoea
34%
Neutropenia
29%
Pyrexia
25%
Anaemia
24%
Nausea
23%
Cough
17%
Thrombocytopenia
17%
Constipation
16%
Fatigue
16%
Pneumonia
15%
Vomiting
15%
Decreased appetite
14%
Upper respiratory tract infection
13%
Asthenia
13%
Colitis
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Aspartate aminotransferase increased
9%
Dyspnoea
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Urinary tract infection
1%
Respiratory failure
1%
Pleural haemorrhage
1%
Streptococcal sepsis
1%
Interstitial lung disease
1%
Skin infection
1%
Pneumonia staphylococcal
1%
Rash erythematous
1%
Accidental overdose
1%
Fungal oesophagitis
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 (duvelisib)Experimental Treatment1 Intervention
INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,565 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,936 Total Patients Enrolled
Alexey V DanilovPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
4 Previous Clinical Trials
146 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood platelet count is at least 30,000 and my neutrophil count is at least 500, without recent transfusions.I haven't taken specific cancer treatments like antibodies, radio-toxins, or targeted therapy recently.I haven't had a stroke, heart attack, severe chest pain, or serious heart rhythm problems needing treatment or a pacemaker in the last 6 months.I have a history of HIV or active hepatitis B or C.I have a long-term liver condition.My kidneys are functioning well enough for treatment.I agree to use birth control during and for 60 days after my treatment.I can have children and have not been sterilized or gone through menopause.I do not have conditions like IBD or chronic diarrhea that affect drug absorption.I do not have any mental health or social issues that would stop me from following the study's requirements.I've had at least one treatment for my condition and it didn't work or my disease didn't improve.I have recovered from side effects of my previous treatment.My bilirubin levels are within twice the normal limit, except for known conditions.I agree to use birth control during and for 60 days after the study treatment.I had a stem cell transplant in the last year or am on low-dose immunosuppressants.I haven't had chemotherapy or radiation in the last 3 weeks.I use more than 30 mg/day of prednisone or its equivalent.I have not used strong CYP3A4 inhibitors or inducers in the last week.I had cancer before, but it's been treated and inactive for over 2 years, or it was a minor skin cancer or in situ carcinoma with no current signs of disease.I do not have uncontrolled immune-related blood issues.I cannot take preventive treatments for pneumocystis or herpes viruses.I have not had major surgery in the last 2 weeks.I currently have an infection that isn't under control.My leukemia is confirmed as B-CLL/SLL without signs of mantle cell lymphoma.I am a woman who can have children and have a recent negative pregnancy test.I can join if I couldn't tolerate ibrutinib or it stopped working for me.My CLL/SLL requires treatment according to the IWCLL 2018 criteria.I can take care of myself and am up and about more than half of my waking hours.I can swallow pills without any issues.I have never taken PI3K inhibitors for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (duvelisib)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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