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Duvelisib After CAR T-Cell Therapy for Lymphoma

Phase 1
Recruiting
Led By Armin Ghobadi, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets FDA-approved criteria for treatment of non-Hodgkin lymphoma (NHL) with axicabtagene ciloleucel (Yescarta), tisagenlecleucel (Kymriah), lisocabtagene maraleucel (Breyanzi) or brexucabtagene autoleucel (Tecartus). Subjects receiving breuxacabtagene autoleucel for treatment of B-cell acute lymphoblastic leukemia (ALL) are not eligible
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 5 years)
Awards & highlights

Study Summary

This trial is testing if a drug that reversibly inhibits PI3K is safe and effective in preventing cytokine release syndrome and enhancing the efficacy of CAR T-cells.

Who is the study for?
This trial is for adults over 18 with certain types of non-Hodgkin lymphoma eligible for CAR T-cell therapy, not B-cell acute lymphoblastic leukemia. Participants must understand the study and consent to it, use effective contraception, and not be pregnant or breastfeeding. They can't have allergies to duvelisib or similar drugs, uncontrolled infections, significant heart/kidney/liver disease, other cancers (except some skin cancers), active CNS involvement by malignancy, or be on strong CYP3A inducers/inhibitors.Check my eligibility
What is being tested?
The trial tests if duvelisib enhances CAR T-cell persistence and efficacy in treating hematologic malignancies post-CAR T-cell therapy. It also examines whether duvelisib can prevent cytokine release syndrome safely. Patients receive this PI3K inhibitor following their standard CAR T-cell treatment.See study design
What are the potential side effects?
Duvelisib may cause side effects like diarrhea, fever, fatigue, rash or itching skin; less common are serious lung problems (pneumonitis), liver damage (hepatotoxicity), severe skin reactions (exfoliative dermatitis) and intestinal perforation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for specific FDA-approved treatments for non-Hodgkin lymphoma.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 5 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
Toxicity as measured by number of adverse events
Secondary outcome measures
Best overall response rate
Craniosynostosis
Cumulative incidence of immune effector cell-associated neurotoxicity syndrome (ICANS)
+7 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

3Treatment groups
Experimental Treatment
Group I: Dose Escalation Stage: DuvelisibExperimental Treatment1 Intervention
Duvelisib is an oral medication taken on a once or twice daily basis on all dosing days. Doses being explored in this study are 15 mg BID (starting dose), 25 mg BID, and 15 mg QD. In the dose escalation stage, patients will receive duvelisib from Day -2 through Day 28. CAR T-cells will be given per standard of care.
Group II: Cohort B Dose Expansion Stage: DuvelisibExperimental Treatment1 Intervention
Patients in Cohort B will receive duvelisib from Day -2 to Day 28 at the maximum tolerated dose (determined in dose expansion stage), followed by two weeks off therapy. This will be followed by 5 additional cycles of duvelisib for days 1-14 of 28 day cycles at the maximum tolerated dose. CAR T-cells will be given per standard of care.
Group III: Cohort A Dose Expansion Stage: DuvelisibExperimental Treatment1 Intervention
Patients in Cohort A will receive duvelisib from Day -2 to Day 28. The dose that will be given will be determined in the dose escalation stage (the maximum tolerated dose). CAR T-cells will be given per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,711 Total Patients Enrolled
SecuraBioIndustry Sponsor
27 Previous Clinical Trials
2,237 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,962 Total Patients Enrolled

Media Library

Duvelisib Clinical Trial Eligibility Overview. Trial Name: NCT05044039 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Cohort B Dose Expansion Stage: Duvelisib, Cohort A Dose Expansion Stage: Duvelisib, Dose Escalation Stage: Duvelisib
Non-Hodgkin's Lymphoma Clinical Trial 2023: Duvelisib Highlights & Side Effects. Trial Name: NCT05044039 — Phase 1
Duvelisib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044039 — Phase 1

Frequently Asked Questions

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

Has Duvelisib been authorized by the FDA?

"Our team at Power assigns a 1 to Duvelisib based on Phase 1 data, which suggests that there is limited evidence around its safety and efficacy."

Answered by AI

Is this an innovative clinical trial?

"Since 2014, Secura Bio Inc. has sponsored 16 ongoing studies of duvelisib across 8 countries and 68 cities. The first trial was Phase 1 & 2 approved, and involved 32 participants; 13 further trials have been conducted since then."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. Clinicaltrials.gov displays the data which indicates that this medical experiment is currently accepting participants, with an original post date of February 28th 2022 and most recent update on June 30th 2022. The trial aims to recruit 43 people from a single location."

Answered by AI

Are there any other investigations looking into the efficacy of Duvelisib?

"Currently, 16 different trials for Duvelisib are in process. None of these active studies have reached Phase 3 yet. The majority of these clinical tests are based out of Boston, Massachusetts; however, there is an expansive network with a total 147 trial sites across the nation."

Answered by AI

Have applications for this research trial been accepted yet?

"Indeed, the documents available on clinicaltrials.gov indicate that this experiment is actively recruiting. It was initially posted in February 2022 and updated last June; 43 people are needed for recruitment at 1 location."

Answered by AI

What illnesses is Duvelisib typically administered to address?

"Duvelisib can be of assistance to patients with refractory small lymphocytic lymphoma, those that have relapsed after their original treatment plan, and those who require a therapeutic procedure following two prior therapies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy
2022. "Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05044039.
~19 spots leftby Dec 2025
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