A Phase 2 interventional study of Duvelisib in Indolent Non-Hodgkin Lymphoma, sponsored by SecuraBio. Completed at 28 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by SecuraBio · Phase 2, Interventional, and Treatment
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
SecuraBio is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have adequate organ function defined by the following laboratory parameters:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle.
Drug: Duvelisib
Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
Drug: Duvelisib
Phosphoinositide 3-kinase (PI3K) inhibitor
Also known as: Copiktra, VS-0145, IPI-145
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
Time frame: Up to 14 months
Progression-free Survival (PFS)
PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \[PET-CT\]) and progressive disease (according to computed tomography \[CT\]). Results reported as months.
Time frame: Up to 2 years
ORR At Specific Timepoints
ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.
Time frame: 6, 12, 18, and 24 months after first dose of study intervention
Duration of Response (DOR)
DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.
Time frame: Up to 2 years
Overall Survival (OS)
OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.
Time frame: Up to 2 years
Lymph Node Response Rate (LNRR)
LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.
Time frame: 14 months
Time To First Response (TTFR)
For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.
Time frame: Up to 14 months
Time To Treatment Failure (TTF)
TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.
Time frame: Up to 2 years
ORR According to 2014 Lugano Criteria
ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).
Time frame: Up to 14 months
| Milestone | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| Started | 52 | 51 |
| Received at least 1 dose of study drug | 51 | 51 |
| Completed | 32 | 36 |
| Not completed | 20 | 15 |
| Withdrew: Consent withdrawn prior to receiving study drug | 1 | 0 |
| Withdrew: Death | 8 | 7 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Participant moved | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Progressive disease | 0 | 1 |
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
| percentage of participants | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| mITT | 65.3 (50.4 to 78.3) | 52.9 (38.5 to 67.1) |
| PP | 62.2 (46.5 to 76.2) | 54.3 (39.0 to 69.1) |
PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \[PET-CT\]) and progressive disease (according to computed tomography \[CT\]). Results reported as months.
| months | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| 2007 Revised IWG Criteria | 16.0 (8.5 to 27.2) | 23.0 (12.5 to 34.3) |
| 2014 Lugano Criteria | 16.0 (8.5 to 27.2) | 23.0 (12.5 to 34.3) |
ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.
| percentage of participants | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| 6 months: 2007 Revised IWG Criteria | 63.3 (48.3 to 76.6) | 49.0 (34.8 to 63.4) |
| 12 months: 2007 Revised IWG Criteria | 65.3 (50.4 to 78.3) | 52.9 (38.5 to 67.1) |
| 18 months: 2007 Revised IWG Criteria | 65.3 (50.4 to 78.3) | 52.9 (38.5 to 67.1) |
| 24 months: 2007 Revised IWG Criteria | 65.3 (50.4 to 78.3) | 52.9 (38.5 to 67.1) |
| 6 months: 2014 Lugano Criteria | 63.3 (48.3 to 76.6) | 47.1 (32.9 to 61.5) |
| 12 months: 2014 Lugano Criteria | 65.3 (50.4 to 78.3) | 51.0 (36.6 to 65.2) |
| 18 months: 2014 Lugano Criteria | 65.3 (50.4 to 78.3) | 51.0 (36.6 to 65.2) |
| 24 months: 2014 Lugano Criteria | 65.3 (50.4 to 78.3) | 51.0 (36.6 to 65.2) |
DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.
| months | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| 2007 Revised IWG Criteria | 21.4 (13.7 to NA) | 32.2 (17.5 to NA) |
| 2014 Lugano Criteria | 21.4 (13.7 to NA) | 32.2 (13.8 to NA) |
OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.
| months | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.
| percentage of participants | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| Lymph Node Response Rate (LNRR) | 64.3 (48.0 to 78.4) | 60.9 (45.4 to 74.9) |
For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.
| months | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| 2007 Revised IWG Criteria | 2.30 (2.1 to 12.9) | 2.30 (2.1 to 12.5) |
| 2014 Lugano Criteria | 2.30 (2.1 to 12.9) | 2.30 (2.1 to 12.5) |
TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.
| months | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| Time To Treatment Failure (TTF) | 12.6 (6.2 to 17.1) | 14.3 (8.0 to 23.0) |
ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).
| percentage of participants | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| mITT | 65.3 (50.4 to 78.3) | 51.0 (36.6 to 65.2) |
| PP | 62.2 (46.5 to 76.2) | 52.2 (36.9 to 67.1) |
Collected over Up to 37 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duvelisib, Continuous and Intermittent Dosing | 8/51 (15.7%) | 13/51 (25.5%) | 49/51 (96.1%) |
| Duvelisib, Intermittent Dosing | 7/51 (13.7%) | 16/51 (31.4%) | 50/51 (98%) |
| Event | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 3/51 | 3/51 |
| COVID-19Infections and infestations | 2/51 | 1/51 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/51 | 2/51 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/51 | 2/51 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/51 | 0/51 |
| AnaemiaBlood and lymphatic system disorders | 0/51 | 1/51 |
| Cardiac arrestCardiac disorders | 1/51 | 0/51 |
| Cardiac failureCardiac disorders | 0/51 | 1/51 |
| Myocardial infarctionCardiac disorders | 0/51 | 1/51 |
| PylorospasmGastrointestinal disorders | 1/51 | 0/51 |
| Event | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 10/51 | 17/51 |
| DiarrhoeaGastrointestinal disorders | 17/51 | 10/51 |
| Alanine aminotransferase increasedInvestigations | 15/51 | 8/51 |
| Aspartate aminotransferase increasedInvestigations | 15/51 | 6/51 |
| COVID-19Infections and infestations | 8/51 | 10/51 |
| PyrexiaGeneral disorders | 9/51 | 9/51 |
| NauseaGastrointestinal disorders | 7/51 | 8/51 |
| HeadacheNervous system disorders | 8/51 | 1/51 |
| FatigueGeneral disorders | 7/51 | 5/51 |
| ConstipationGastrointestinal disorders | 6/51 | 3/51 |
All-Treated (AT) Analysis Set: All participants who receive at least 1 dose of duvelisib.
| Age, Continuous(years) | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing | Total |
|---|---|---|---|
| Mean | 60.5 ± 12.15 | 63.9 ± 11.40 | 62.2 ± 11.85 |
| Sex: Female, Male(Participants) | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing | Total |
|---|---|---|---|
| Female | 28 | 27 | 55 |
| Male | 23 | 24 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 48 | 50 | 98 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Duvelisib, Continuous and Intermittent Dosing | Duvelisib, Intermittent Dosing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 14 | 9 | 23 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 36 | 42 | 78 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Jul 2023, 46 months.
Results were first posted in Sep 2024, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Duvelisib