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PI3K Inhibitor

Duvelisib for Peripheral T-Cell Lymphoma (PRIMO Trial)

Phase 2
Waitlist Available
Research Sponsored by SecuraBio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following: failed to achieve at least a partial response after 2 or more cycles; failed to achieve a complete response after 6 or more cycles; and/or progressed after an initial response For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Age ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until death, 6 months
Awards & highlights

PRIMO Trial Summary

This trial is testing a new cancer drug for patients with a certain type of T cell lymphoma who have relapsed or who haven't responded to other treatments.

Who is the study for?
This trial is for adults with relapsed or refractory Peripheral T Cell Lymphoma (PTCL) who have tried at least one treatment without success. They must have a specific type of PTCL confirmed by pathology and measurable disease. People can't join if they've had prior PI3K inhibitor treatments, CNS lymphoma involvement, are on high-dose steroids or immunosuppressants, or have an active systemic infection.Check my eligibility
What is being tested?
The study tests Duvelisib, an oral medication targeting certain enzymes in cancer cells (PI3K-δ,γ), to see its effectiveness in patients with PTCL that has not responded well to previous treatments. It's a Phase 2 trial conducted across multiple centers where all participants receive the drug.See study design
What are the potential side effects?
Duvelisib may cause side effects like diarrhea, nausea, fatigue, coughing, fever, rash and potential infections due to lowered immune response. Some people might experience liver problems or lung issues.

PRIMO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received at least two rounds of a previous treatment that aimed to cure your condition, but it did not work as expected. If you have CD30+ ALCL, you have either failed a treatment called brentuximab vedotin, or you are not eligible for it, or you cannot tolerate it.

PRIMO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until death, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until death, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants with Treatment-emergent Adverse events (TEAEs) as Assessed by CTCAE v4.0
+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%
Renal failure acute
3%
Toxic skin eruption
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%
Pneumonia klebsiella
1%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Mental impairment
1%
Pneumonia staphylococcal
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Proctitis
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

PRIMO Trial Design

3Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment1 Intervention
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those patients with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).
Group II: Dose Optimization Phase: Cohort 2Experimental Treatment1 Intervention
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Group III: Dose Optimization Phase: Cohort 1Experimental Treatment1 Intervention
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles.
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?

SecuraBioLead Sponsor
27 Previous Clinical Trials
2,177 Total Patients Enrolled
David Cohan, MDStudy DirectorSecuraBio Chief Medical Officer
8 Previous Clinical Trials
604 Total Patients Enrolled

Frequently Asked Questions

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

Could you detail other research investigations that have used Duvelisib?

"In 2014, the Dana Farber Cancer Institute initiated research into duvelisib. Thus far, 13 studies have been concluded and 16 are still in progress - with many located within Chicago's metropolitan area."

Answered by AI

What has Duvelisib been employed to address medically?

"Duvelisib has been proven to be efficacious against refractory, relapsed small lymphocytic lymphoma and other conditions including therapeutic procedure, two prior therapies, and refractory anemias."

Answered by AI

Are there numerous healthcare facilities implementing this experiment in Canada?

"This trial is being conducted in 19 locations, including Chicago, Stony Brook and Irvine. To minimize travel time for participants, it is prudent to select the closest site near you."

Answered by AI

What is the current enrollment of participants in this experiment?

"This clinical trial has reached its recruitment target and is not currently open to new candidates. It was initially posted on February 22nd 2018, with the last update being May 3rd 2022. Alternately, there are 1731 trials regarding lymphoma and 16 studies for Duvelisib that are actively recruiting patients as of now."

Answered by AI

Does this scientific experiment require more participants?

"Unfortunately, no more candidates may join this trial as it was last updated on May 3rd 2022. If you are still hoping to find a study that matches your needs, 1731 trials for lymphoma and 16 studies involving Duvelisib are currently accepting patients."

Answered by AI

Has Duvelisib received governmental authorization to be used in practice?

"According to our experts at Power, Duvelisib's safety can be assessed as a 2. This is due to it being in the Phase 2 of this clinical trial process, meaning there has been some data collected that supports its security but none indicating effectiveness."

Answered by AI

Does this research venture introduce a new methodology?

"Secura Bio, Inc. kicked off the first Duvelisib clinical trial in 2014 with 32 patients. This study was followed by Phase 1 & 2 approval and today it is being tested across 68 cities in 8 nations - there are 16 active trials for this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
2018. "A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03372057.
~15 spots leftby Apr 2025
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