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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
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 ULN
Total bilirubin =< 1.5 ULN (unless due to liver involvement, hemolysis, or Gilbert's disease)
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

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 • NCT02004522
21%
Neutropenia
18%
Infusion related reaction
14%
Cough
12%
Diarrhoea
12%
Fatigue
12%
Rash
11%
Nausea
11%
Asthenia
10%
Anaemia
10%
Paraesthesia
10%
Pyrexia
8%
Constipation
8%
Headache
8%
Upper respiratory tract infection
8%
Bronchitis
6%
Pruritus
6%
Vomiting
6%
Dyspnoea
6%
Thrombocytopenia
6%
Insomnia
6%
Paraesthesia oral
5%
Hypotension
5%
Back pain
5%
Muscle spasms
5%
Oedema peripheral
3%
Dizziness
3%
Arthralgia
3%
Hypertension
3%
Hyperkalaemia
3%
Pneumonia
3%
Abdominal pain upper
3%
Nasopharyngitis
3%
Decreased appetite
3%
Dyspepsia
2%
Febrile neutropenia
2%
Weight decreased
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Abdominal pain
2%
Hypokalaemia
2%
Rhinorrhoea
2%
Escherichia sepsis
2%
Respiratory tract infection
2%
Pain in extremity
1%
Rash maculo-papular
1%
Colitis
1%
Clostridium difficile infection
1%
Cardiac failure
1%
Productive cough
1%
Dehydration
1%
Neutropenic sepsis
1%
Sepsis
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Lymph node pain
1%
Atrial fibrillation
1%
Disease progression
1%
Cholecystitis
1%
Drug hypersensitivity
1%
Streptococcal bacteraemia
1%
Device related infection
1%
Herpes virus infection
1%
Ischaemic stroke
1%
Renal failure acute
1%
Angina pectoris
1%
Oesophageal ulcer
1%
Portal hypertensive gastropathy
1%
Infusion site extravasation
1%
Hepatic failure
1%
Contrast media allergy
1%
Pneumonia bacterial
1%
Escherichia urinary tract infection
1%
Pneumonia viral
1%
Gastroenteritis
1%
Fall
1%
Hyponatraemia
1%
Hypercalcaemia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Malignant melanoma
1%
Glioblastoma multiforme
1%
Malignant pleural effusion
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of lung
1%
Pulmonary embolism
1%
Laryngeal stenosis
1%
Peripheral embolism
1%
Dry mouth
1%
Tachycardia
1%
Enterocolitis
1%
Lower respiratory tract infection
1%
Chronic sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ofatumumab
Duvelisib

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
~750

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

Duvelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03892044 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (duvelisib, nivolumab)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Duvelisib Highlights & Side Effects. Trial Name: NCT03892044 — Phase 1
Duvelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03892044 — Phase 1

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
~1 spots leftby Mar 2025