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PI3K Inhibitor

Duvelisib for Non-Hodgkin's Lymphoma (TEMPO 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

TEMPO Trial Summary

This trial will study whether taking a break from the drug duvelisib affects tumor responses and safety.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

TEMPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
DOR (Duration of Response)
LNRR (Lymph Node Response Rate)
+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%
Arthralgia
7%
Pruritus
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%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Pneumonia aspiration
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia staphylococcal
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

TEMPO Trial Design

2Treatment groups
Experimental Treatment
Group I: Duvelisib, Intermittent DosingExperimental Treatment1 Intervention
Duvelisib 25 mg BID dosed two weeks on and two weeks off.
Group II: Duvelisib, Continuous and Intermittent DosingExperimental Treatment1 Intervention
Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed two weeks on and two weeks off of each subsequent 4-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
FDA approved

Find a Location

Who is running the clinical trial?

SecuraBioLead Sponsor
27 Previous Clinical Trials
2,178 Total Patients Enrolled
David Cohan, MDStudy DirectorSecuraBio Chief Medical Officer
8 Previous Clinical Trials
605 Total Patients Enrolled

Frequently Asked Questions

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

Have any additional experiments utilized Duvelisib?

"At present, 16 clinical trials are actively researching Duvelisib with none currently in the 3rd phase. Several studies based in Boston, Massachusetts exist alongside 147 other trial sites across the world studying this medication."

Answered by AI

Are there still opportunities for individuals to partake in this medical trial?

"The trial's page on clinicaltrials.gov denotes that this medical study is not presently recruiting patients, despite being initially posted in September 2019 and recently updated in May 2021. However, 1765 other trials are actively seeking enrollees at the present time."

Answered by AI

For what common medical purposes is Duvelisib usually prescribed?

"Duvelisib is the go-to treatment of choice for refractory, relapsed small lymphocytic lymphoma. On top of that, it may offer relief to patients suffering from therapeutic procedure, two prior therapies and refractory anemias too."

Answered by AI

Has Duvelisib been federally sanctioned for use?

"Our team has rated the safety of Duvelisib a 2, as this is only Phase 2 and there is currently no evidence that it's effective. However, there are some studies indicating its relative saftey."

Answered by AI

How many locations in the US are currently conducting this clinical experiment?

"Patients are welcome to enroll in this medical trial at Research Medical Center located in Kansas City, Missouri, Comprehensive Cancer Centers of Nevada based out of Las Vegas and Florida Cancer Specialists - Panhandle situated in Tallahassee. Other recruitment sites abound across the country."

Answered by AI

What is the current enrollment capacity of this clinical trial?

"As of the 17th of May 2021, this trial is not accepting patients. It was initially listed on September 24th 2019 and has since been updated multiple times. Patients searching for studies related to lymphoma can choose from a pool of 1,749 options while those seeking out Duvelisib trials have 16 available opportunities."

Answered by AI

Has this clinical trial ever been conducted before?

"At present, 16 trials involving Duvelisib are taking place across 8 countries and 68 cities. This drug was initially tested in 2014 through a Secura Bio, Inc.-sponsored study consisting of 32 participants that completed its Phase 1 & 2 stages. Subsequently, 13 studies have been concluded since then."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma
2019. "A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038359.
~18 spots leftby Apr 2025
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