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PI3K Inhibitor

Duvelisib for Diffuse Large B-Cell Lymphoma

Phase < 1
Recruiting
Led By Edmund K Waller, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a biopsy proven diagnosis of relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Sexually active males must use a condom during intercourse from enrollment into this study until at least 12 months after tisagenlecleucel infusion and until CAR-T cells are no longer present by qPCR on two consecutive tests (qPCR tests will be available upon request). A condom is required of all sexually active male patients to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months following car-t cell infusion
Awards & highlights

Study Summary

This trial is testing how well a drug called duvelisib exposure works to enhance the immune profiles of T cells in patients with DLBCL.

Who is the study for?
This trial is for adults with relapsed/refractory diffuse large B-cell lymphoma. Participants must be in good physical condition (ECOG < 2), have normal organ function, and not be pregnant or breastfeeding. They should agree to use effective contraception and not donate blood or organs during the study. People with CNS lymphoma involvement, autoimmune diseases, active infections, recent immunosuppressive therapy, or prior CD19 directed therapy are excluded.Check my eligibility
What is being tested?
The DEEP T CELLS Study is testing whether taking duvelisib before manufacturing CAR-T cells can improve the immune profiles of T cells in patients with difficult-to-treat diffuse large B-cell lymphoma. Duvelisib is an oral drug that may make T cells more efficient for later CAR-T cell treatment.See study design
What are the potential side effects?
Duvelisib might cause diarrhea, liver enzyme changes, fatigue, fever, coughing and other respiratory issues. It could also increase the risk of infections due to its effect on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My biopsy shows I have relapsed or refractory DLBCL.
Select...
I am a man who will use a condom for 12 months after treatment and until tests confirm the treatment is not in my system.
Select...
I have been using a reliable birth control method for at least 3 months.
Select...
I can do all my daily activities without help.
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I agree not to donate blood or organs while on treatment and for a year after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months following car-t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months following car-t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fold-change increase in CD27/CD28 double positive T cells
Secondary outcome measures
Change in proportion of CD27/28 double positive T cells and CD4/8 double negative T cells
Frequency of intensive care unit (ICU) transfers due to cytokine release syndrome (CRS) and/or neurotoxicity
Incidence of grade III-IV adverse events
+3 more

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522
50%
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%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Respiratory failure
1%
Skin infection
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Proctitis
1%
Pneumonia aspiration
1%
Rash erythematous
1%
Interstitial lung disease
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 Treatment2 Interventions
Patients receive duvelisib PO BID for 2 weeks prior to collection of CAR-T cells in the absence of disease progression or unacceptable toxicity. Patients then receive tisagenlecleucel via infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
2019
Completed Phase 2
~360
Duvelisib
2016
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,015 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,676 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,926,009 Total Patients Enrolled

Media Library

B-Cell Lymphoma Research Study Groups: Treatment (duvelisib)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available vacancies in this clinical investigation?

"Affirmative. According to information posted on clinicaltrials.gov, this medical research project is actively searching for individuals to participate in the trial. The initial posting was published on January 13th 2022 and has since been modified as recently as June 15th 2022. At present, 20 patients are needed at two separate sites."

Answered by AI

What therapeutic effects is Duvelisib intended to produce?

"Many practitioners prescribe Duvelisib to treat second or subsequent relapses of b-cell precursor acute lymphoblastic leukemia. This drug can also be efficacious in treating refractory anemias, lymphoma, follicular disease and unresponsive cases of the same cancer type."

Answered by AI

What is the aggregate size of the cohort participating in this experiment?

"Affirmative. The clinical trial's listing on clinicaltrials.gov confirms that, as of June 15th 2022, recruitment is in progress for 20 patients across two medical centres. This study was initially posted to the website on January 13th 2022."

Answered by AI

Have prior tests demonstrated any efficacy of Duvelisib?

"The initial research into duvelisib began in 2014, at the Dana Farber Cancer Institute. 25 studies have since been completed and there are currently 31 active trials occuring across Chicago, Illinois."

Answered by AI

Is this experiment the inaugural attempt of its kind?

"As of today, there are 31 active trials for Duvelisib that span 26 countries and 156 cities. The initial investigation was conducted by Secura Bio Inc in 2014 with a limited sample size of 32 participants. Since then, 25 other experiments have been completed to further assess the drug's efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study
Edmund Waller 2022. "Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04890236.
~3 spots leftby Aug 2024
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