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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of progression free survival (PFS) at 12 months
Secondary outcome measures
Duration of response (DOR)
Duration of therapy
Incidence of toxicity
+2 moreOther outcome measures
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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Pruritus
7%
Arthralgia
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%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Mental impairment
1%
Pneumonia staphylococcal
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
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
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
565 Previous Clinical Trials
1,921,445 Total Patients Enrolled
97 Trials studying Lymphoma
6,455 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,138 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,385 Patients Enrolled for Lymphoma
Alexey V DanilovPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
3 Previous Clinical Trials
119 Total Patients Enrolled
2 Trials studying Lymphoma
39 Patients Enrolled for Lymphoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what type of conditions is Duvelisib usually prescribed?
"Duvelisib is a routinely prescribed medication for refractory, relapsed small lymphocytic lymphoma. This pharmaceutical agent also has therapeutic value in managing two prior therapies and refractory anemias."
Answered by AI
Are there any vacancies for participants in this medical experiment?
"This trial, initially posted on May 13th 2020 and last revised on October 7th 2022, is not currently recruiting for participants as made evident by clinicaltrials.gov; however, there are 3,711 other studies that could use volunteers right now."
Answered by AI
How many test subjects are enrolled in this clinical experiment?
"Patient recruitment for this trial ended on October 7th 2022. Initially posted on May 13th 2020, the study is no longer accepting enrollees. For those looking to join other clinical trials, there are currently 3695 studies actively recruiting patients with leukemia and 16 research projects seeking participants taking Duvelisib."
Answered by AI
To what extent does Duvelisib pose a risk to those taking it?
"Our team of researchers at Power have determined that Duvelisib can be assigned a safety rating of 2, as there is evidence to support its safety but none yet for efficacy."
Answered by AI
Could you please elucidate the other experiments that have centered around Duvelisib?
"At this time, the research on Duvelisib is largely in Phase 1 and 2 trials with no studies reaching phase 3. These investigations are being held at 147 trial sites across America; notably, many are located within Saint Louis, Missouri."
Answered by AI
Is this the inaugural research of its type?
"Since its inception in 2014, Duvelisib has advanced through the preclinical stages of drug development and is now being actively researched. Secura Bio, Inc. initially sponsored a trial involving 32 patients which allowed for Phase 1 & 2 drug approval to be granted. Currently 16 clinical studies are underway across 8 countries and 68 cities worldwide."
Answered by AI
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