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PI3K Inhibitor
Duvelisib + Nivolumab for Advanced Lymphoma
Phase 1
Waitlist Available
Led By Jennifer A Woyach, MD
Research Sponsored by David Bond, MD
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 up to 3 years
Awards & highlights
Study Summary
This trial is studying duvelisib and nivolumab to treat Richter syndrome or transformed follicular lymphoma.
Who is the study for?
This trial is for patients with Richter syndrome or transformed follicular lymphoma. Participants must have certain blood test levels within normal ranges, not be pregnant or breastfeeding, and agree to use effective birth control. They should not have other active cancers, severe heart issues, uncontrolled infections, gastrointestinal conditions that affect absorption of drugs, CNS involvement by their cancer, or recent stem cell transplants.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Duvelisib and Nivolumab. Duvelisib blocks enzymes needed for tumor growth while Nivolumab boosts the immune system's ability to fight cancer. The study aims to find the best dose and see if this drug combo is more effective than using each drug alone in treating these types of lymphoma.See study design
What are the potential side effects?
Potential side effects include liver enzyme elevation which may indicate liver damage; fatigue; digestive issues like nausea or diarrhea; increased risk of infection due to immune system effects; possible allergic reactions; and complications from organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum-tolerated dose (MTD) of duvelisib
Secondary outcome measures
Overall response rate
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Changes in T, B, and NK cell number and function
Nivolumab
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%
Toxic skin eruption
3%
Renal failure acute
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%
Pneumonia staphylococcal
1%
Pneumonia klebsiella
1%
Urinary tract infection
1%
Skin infection
1%
Rash erythematous
1%
Mental impairment
1%
Upper gastrointestinal haemorrhage
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Pleural haemorrhage
1%
Proctitis
1%
Interstitial lung disease
1%
Pneumonia aspiration
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, nivolumab)Experimental Treatment2 Interventions
Patients receive duvelisib PO BID on days 1-28 and nivolumab IV over 60 minutes on days 1 and 15. 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
Nivolumab
2014
Completed Phase 3
~4750
Duvelisib
2016
Completed Phase 3
~760
Find a Location
Who is running the clinical trial?
David Bond, MDLead Sponsor
3 Previous Clinical Trials
103 Total Patients Enrolled
Jennifer A Woyach, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (duvelisib, nivolumab)
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 is the total enrollment of participants for this trial?
"Unfortunately, this clinical trial has already concluded its recruitment period. The initial posting was on November 5th 2019 and the most recent amendment happened on May 31st 2022. However, those interested in other studies may be pleased to know that there are currently 4130 trials involving leukemia patients actively recruiting as well as 730 research initiatives for Duvelisib."
Answered by AI
Has a similar investigation ever been conducted before?
"Since 2012, Duvelisib has been subject to intensive research. Ono Pharmaceutical Co. Ltd sponsored the initial trial in 2012 and enrolled 659 patients for Phase 1 & 2 testing. Currently there are 730 active trials of this drug taking place across 49 countries and 2361 cities worldwide."
Answered by AI
Are there any available slots for participants in this experimentation?
"At this time, enrollment for the study has been closed. Initially announced on 11th May 2019 and last amended on 31st May 2022; individuals seeking to actively participate in clinical trials may explore 4130 other studies devoted to treating leukemia or 730 specifically researching Duvelisib."
Answered by AI
Has there been any precedent for utilizing Duvelisib in clinical investigations?
"At present, 730 studies are being conducted to assess the efficacy of Duvelisib. Of these investigations, 82 have reached Phase 3 status in clinical trials. Primarily situated in Basel, BE; nevertheless, there exist 40423 other sites also testing this drug's therapeutic potential."
Answered by AI
Has Duvelisib been accepted by the FDA for use as a medication?
"With limited data on safety and efficacy, Duvelisib has been scored a 1 for risk level by the Power team."
Answered by AI
Could you describe the typical applications of Duvelisib?
"Duvelisib is available to patients with metastatic urothelial carcinoma of the ureter, hepatocellular carcinoma, and malignant melanomas."
Answered by AI
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