A Phase 3 interventional study of Duvelisib and Placebo in Follicular Lymphoma, sponsored by SecuraBio. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by SecuraBio · Phase 3, Interventional, and Treatment
A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.
Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's enrollment of 13 is below the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →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.
Diagnosis of CD20-positive FL:
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 biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Drug: Duvelisib · Drug: Rituximab
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules. Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Drug: Placebo · Drug: Rituximab
PI3K Inhibitor
Also known as: Copiktra, IPI-145
Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
Also known as: Rituxan, MabThera
Progression-Free Survival (PFS)
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
Time frame: Until disease progression, for up to 5 years from randomization
Overall Response Rate (ORR)
Time frame: Until disease progression, for up to 5 years from randomization
| Milestone | Duvelisib + Rituximab | Placebo + Rituximab |
|---|---|---|
| Started | 6 | 7 |
| Completed | 2 | 0 |
| Not completed | 4 | 7 |
| Withdrew: Patient ineligible-medical monitor | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Adverse event and investigator decision | 1 | 0 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Protocol-specified disease progression | 0 | 4 |
| Withdrew: Termination of study bysponsor | 0 | 1 |
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
No measurements were reported for this outcome.
| Participants | Duvelisib + Rituximab | Placebo + Rituximab |
|---|---|---|
| Complete Response | 3 | 0 |
| Partial Response | 2 | 1 |
| Stable Disease | 0 | 3 |
| Progressive Disease | 0 | 2 |
Collected over 15 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duvelisib + Rituximab | 0/6 (0%) | 5/6 (83.3%) | 6/6 (100%) |
| Placebo + Rituximab | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | Duvelisib + Rituximab | Placebo + Rituximab |
|---|---|---|
| PneumoniaInfections and infestations | 2/6 | 0/7 |
| Interstitial Lung DiseaseRespiratory, thoracic and mediastinal disorders | 2/6 | 0/7 |
| Gastrointestinal InflammationGastrointestinal disorders | 1/6 | 0/7 |
| PyrexiaGeneral disorders | 1/6 | 0/7 |
| Pneumonia CytomegaloviralInfections and infestations | 1/6 | 0/7 |
| Chronic Obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/6 | 0/7 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/6 | 0/7 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/6 | 0/7 |
| Event | Duvelisib + Rituximab | Placebo + Rituximab |
|---|---|---|
| Alanine aminotransferase increasedInvestigations | 3/6 | 0/7 |
| Aspartate aminotransferase increasedInvestigations | 3/6 | 0/7 |
| NeutropeniaBlood and lymphatic system disorders | 2/6 | 0/7 |
| AstheniaGeneral disorders | 2/6 | 2/7 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/6 | 2/7 |
| AnxietyPsychiatric disorders | 0/6 | 2/7 |
| ChillsGeneral disorders | 0/6 | 2/7 |
| FatigueGeneral disorders | 0/6 | 2/7 |
| Upper respiratory tract infectionInfections and infestations | 0/6 | 2/7 |
| Amylase increasedInvestigations | 1/6 | 0/7 |
| Age, Categorical(Participants) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 2 | 5 | 7 |
| Age, Continuous(years) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| Median | 56.5 (55 to 77) | 68 (47 to 79) | 68 (55 to 77) |
| Sex: Female, Male(Participants) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 2 | 6 | 8 |
| Race (NIH/OMB)(Participants) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 5 | 5 | 10 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
| Australia | 1 | 0 | 1 |
| Italy | 2 | 1 | 3 |
| Spain | 1 | 1 | 2 |
| Poland | 1 | 2 | 3 |
| Canada | 0 | 1 | 1 |
| France | 0 | 1 | 1 |
| Eastern Cooperative Oncology Group Performance Status(Participants) | Duvelisib + Rituximab | Placebo + Rituximab | Total |
|---|---|---|---|
| 0=Fully active, no restrictions | 4 | 6 | 10 |
| 1= Restricted in physically strenuous activity | 2 | 1 | 3 |
| 2=Ambulatory more than 50% of waking hours | 0 | 0 | 0 |
| 3=Confined to bed or chair more than 50% of waking | 0 | 0 | 0 |
| 4=Completely disabled | 0 | 0 | 0 |
| 5=Dead | 0 | 0 | 0 |
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duvelisib