Duvelisib for T-Cell Lymphoma

Washington University School of Medicine, Saint Louis, MO
T-Cell Lymphoma+1 More ConditionsDuvelisib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test if a drug called duvelisib is safe and effective in treating T-cell lymphomas.

Eligible Conditions
  • T-Cell Lymphoma
  • Indolent B Cell Non-Hodgkin Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Duvelisib
1
Ruxolitinib
1
Duvelisib

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

100 days after transplant
Overall response rate (ORR)
2 years
Overall survival (OS)
Progression-free survival (PFS)
Month 13
Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events
Safety and tolerabilty as measured by number of study treatment related adverse events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Duvelisib
1
Ruxolitinib
1
Duvelisib

Side Effects for

Ofatumumab
21%Neutropenia
18%Infusion related reaction
14%Cough
12%Fatigue
12%Diarrhoea
12%Rash
11%Asthenia
11%Nausea
10%Anaemia
10%Paraesthesia
10%Pyrexia
8%Headache
8%Constipation
8%Upper respiratory tract infection
8%Bronchitis
6%Thrombocytopenia
6%Pruritus
6%Insomnia
6%Paraesthesia oral
6%Vomiting
6%Dyspnoea
5%Oedema peripheral
5%Back pain
5%Hypotension
5%Muscle spasms
3%Hyperkalaemia
3%Pneumonia
3%Decreased appetite
3%Dyspepsia
3%Arthralgia
3%Hypertension
3%Abdominal pain upper
3%Nasopharyngitis
3%Dizziness
2%Abdominal pain
2%Respiratory tract infection
2%Hypokalaemia
2%Alanine aminotransferase increased
2%Febrile neutropenia
2%Rhinorrhoea
2%Escherichia sepsis
2%Weight decreased
2%Aspartate aminotransferase increased
2%Pain in extremity
1%Neutropenic sepsis
1%Haemolytic anaemia
1%Colitis
1%Portal hypertensive gastropathy
1%Infusion site extravasation
1%Contrast media allergy
1%Pneumonia viral
1%Hypercalcaemia
1%Glioblastoma multiforme
1%Squamous cell carcinoma of lung
1%Ischaemic stroke
1%Pulmonary embolism
1%Laryngeal stenosis
1%Productive cough
1%Hyponatraemia
1%Deep vein thrombosis
1%Rash maculo-papular
1%Oesophageal ulcer
1%Cholecystitis
1%Sepsis
1%Streptococcal bacteraemia
1%Clostridium difficile infection
1%Hyperglycaemia
1%Dehydration
1%Renal failure acute
1%Hepatic failure
1%Device related infection
1%Lymph node pain
1%Drug hypersensitivity
1%Peripheral embolism
1%Hypervolaemia
1%Atrial fibrillation
1%Disease progression
1%Herpes virus infection
1%Squamous cell carcinoma
1%Malignant melanoma
1%Dry mouth
1%Malignant pleural effusion
1%Pneumonia bacterial
1%Fall
1%Angina pectoris
1%Escherichia urinary tract infection
1%Gastroenteritis
1%Cardiac failure
1%Tachycardia
1%Enterocolitis
1%Lower respiratory tract infection
1%Chronic sinusitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02004522) in the Ofatumumab ARM group. Side effects include: Neutropenia with 21%, Infusion related reaction with 18%, Cough with 14%, Fatigue with 12%, Diarrhoea with 12%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Duvelisib Maintenance
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Duvelisib · No Placebo Group · Phase 2

Duvelisib MaintenanceExperimental Group · 2 Interventions: Peripheral blood draw, Duvelisib · Intervention Types: Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral blood draw
2017
Completed Phase 2
~60
Duvelisib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,847 Previous Clinical Trials
2,280,581 Total Patients Enrolled
SecuraBioIndustry Sponsor
27 Previous Clinical Trials
2,173 Total Patients Enrolled
Amanda Cashen, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
349 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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