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Duvelisib Maintenance for T-Cell Lymphoma
Phase 2
Recruiting
Led By Amanda Cashen, 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
Diagnosis of T cell non-Hodgkin lymphoma, including peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T cell lymphoma, and systemic anaplastic large cell lymphoma
At least 18 years of age at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test if a drug called duvelisib is safe and effective in treating T-cell lymphomas.
Who is the study for?
Adults with certain types of T-cell lymphoma eligible for or have had a stem cell transplant can join. They must be generally healthy, not pregnant, and agree to use contraception. Excluded are those with severe lung disease, recent heart issues, drug allergies similar to duvelisib's components, active infections or other cancers needing treatment.Check my eligibility
What is being tested?
The trial is testing if taking the drug duvelisib after a stem cell transplant is safe and helps patients with T-cell lymphomas live longer without their cancer getting worse. Participants will receive regular doses of duvelisib and undergo blood tests to monitor effects.See study design
What are the potential side effects?
Duvelisib may cause side effects like diarrhea, liver problems, infections due to low white blood cells count (neutropenia), rash or other skin reactions, tiredness (fatigue), fever, coughing and trouble breathing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of T cell non-Hodgkin lymphoma.
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I am 18 years old or older.
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I am eligible for or have had a stem cell transplant using my own cells within the last month.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidneys, liver, and blood are functioning within the required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Overall response rate (ORR)
Overall survival (OS)
Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events
+1 moreSide 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%
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: Duvelisib MaintenanceExperimental Treatment2 Interventions
Duvelisib maintenance at 25 mg PO BID after count recovery (approximately 30 days after transplant) for one year. If the patient is in a complete remission at day +100, with no evidence of disease on PET/CT, then the dosing schedule of duvelisib may be changed to 25 mg BID for 14 days, then 14 days off in 28 day cycles (at the treating physician's discretion). If the patient has residual disease, duvelisib will continue at 25 mg BID until they have a negative PET CT. PET CTs will be completed every 3 months for patients with residual disease. Duvelisib maintenance will be continued for one year post-transplant.
Starting on 06/10/2021, all new participants will be enrolled to take 25 mg BID of duvelisib on days 1-14 of a 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~760
Peripheral blood draw
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,720 Total Patients Enrolled
SecuraBioIndustry Sponsor
27 Previous Clinical Trials
2,244 Total Patients Enrolled
Amanda Cashen, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive preventive treatments for certain infections.I have no active cancer except for certain skin, cervical, bladder, or prostate cancers that don't need treatment.I do not have active hepatitis B or C.I have not received a live vaccine within the last 6 weeks.I am using effective birth control and have a negative pregnancy test.I have not had tuberculosis in the last 2 years.I am currently being treated for an infection.I haven't taken strong CYP3A affecting drugs or foods in the last 2 weeks.I am not currently on, nor have I been on any experimental therapy in the last 4 weeks.I am currently taking high doses of steroids or other drugs that weaken my immune system.I have a history of chronic liver disease.I have been diagnosed with a type of T cell non-Hodgkin lymphoma.I am 18 years old or older.I do not have conditions like IBD or chronic diarrhea that affect drug absorption.I do not have any serious ongoing illnesses like heart failure or uncontrolled infections.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 lung condition that severely affects my breathing.I am eligible for or have had a stem cell transplant using my own cells within the last month.I can take care of myself and am up and about more than half of my waking hours.My kidneys, liver, and blood are functioning within the required ranges.I have HIV but my CD4+ T-cell count is above 350 and I haven't had major HIV-related infections in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Duvelisib Maintenance
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.
Does this experiment constitute a pioneering endeavor?
"Presently, Secura Bio, Inc. is running 16 trials for Duvelisib in cities across 8 nations. This series of clinical studies began in 2014 with a Phase 1 & 2 trial hosting 32 participants and has since concluded 15 further experiments."
Answered by AI
Is this medical study currently accepting new participants?
"Data from clinicaltrials.gov demonstrates that recruitment for this trial is still in process. It was first announced on July 23rd 2020, and the most recent update occurred on July 18th 2022."
Answered by AI
What precautions should patients take when being prescribed Duvelisib?
"Our team has determined that duvelisib is relatively safe, receiving a score of 2 on our grading system. This is because it's currently in Phase 2 trials which have yielded some data regarding safety but not efficacy."
Answered by AI
To what maladies is Duvelisib typically prescribed?
"Duvelisib is frequently administered to patients with refractory, relapsed small lymphocytic lymphoma. It may also be used in therapeutic procedures and as a last-line treatment for refractory anemias following two prior therapies."
Answered by AI
How many individuals has this research enrolled thus far?
"Affirmative. According to the information stored on clinicaltrials.gov, this research trial is presently accepting participants; it was first posted on July 23rd 2020 and last updated on July 18th 2022. The study requires 36 patients from 1 site only."
Answered by AI
What precedent has been set with regard to Duvelisib-based research?
"Currently, 16 studies are being conducted to further investigate the efficacy of Duvelisib. None of these active trials is in Phase 3 yet. The majority of research for this drug takes place in Boston, MA but there are 147 clinical sites across the world researching it as well."
Answered by AI
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