A Phase 1/2 interventional study of Duvelisib and Rituximab in CD20+ Follicular Lymphoma, sponsored by SecuraBio. Terminated at 21 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by SecuraBio · Phase 1/2, Interventional, and Treatment
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.
The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's enrollment of 55 is above 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.
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.
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 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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Drug: Duvelisib · Drug: Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Drug: Duvelisib · Drug: Obinutuzumab
PI3K Inhibitor
Also known as: Copiktra, IPI-145
monoclonal antibody
Also known as: Rituxan/MabThera®
monoclonal antibody
Also known as: GAZYVA/GAZYVARO™
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time frame: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
Time frame: Up to 2 years from the first dose of study treatment
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
Time frame: Up to 30 days after the last dose of study treatment
Overall Response Rate (ORR)
Time frame: Up to 2 years from the first dose of study treatment
Duration of Response (DOR)
The median DOR was non-estimable.
Time frame: Up to 2 years from the first dose of study treatment
Overall Survival (OS)
Time frame: Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Time frame: Every 4 weeks for 16 weeks
| Milestone | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Started | 27 | 28 |
| Completed | 1 | 0 |
| Not completed | 26 | 28 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Termination of study by sponsor | 20 | 20 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Other reasons | 6 | 4 |
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 | 1 | 0 |
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Complete Response Rate (CRR)- Part 2 | 11 | 10 |
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| TEAEs assessed as ≥ Grade 3 | 24 | 19 |
| TEAEs ≥ Grade 3 assessed as related to duvelisib | 23 | 17 |
| TEAEs ≥ Grade 3 assessed as related to anti-CD20 | 11 | 2 |
| participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Complete Response | 11 | 10 |
| Partial Response | 13 | 16 |
| Stable Disease | 1 | 0 |
The median DOR was non-estimable.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
No measurements were reported for this outcome.
Collected over 35 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duvelisib and Obinutuzumab | 0/27 (0%) | 16/27 (59.3%) | 26/27 (96.3%) |
| Duvelisib and Rituximab | 1/28 (3.6%) | 10/28 (35.7%) | 27/28 (96.4%) |
| Event | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| PyrexiaGeneral disorders | 4/27 | 2/28 |
| DiarrhoeaGastrointestinal disorders | 2/27 | 4/28 |
| ColitisGastrointestinal disorders | 2/27 | 1/28 |
| Alanine aminotransferase increasedInvestigations | 2/27 | 0/28 |
| RashSkin and subcutaneous tissue disorders | 2/27 | 1/28 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/27 | 0/28 |
| OdynophagiaGastrointestinal disorders | 1/27 | 0/28 |
| StomatitisGastrointestinal disorders | 1/27 | 0/28 |
| FatigueGeneral disorders | 1/27 | 0/28 |
| Mucosal InflammationGeneral disorders | 1/27 | 0/28 |
| Event | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 11/27 | 16/28 |
| Alanine aminotransferase increasedInvestigations | 13/27 | 9/28 |
| Aspartate aminotransferase increasedInvestigations | 13/27 | 8/28 |
| NauseaGastrointestinal disorders | 12/27 | 7/28 |
| FatigueGeneral disorders | 8/27 | 9/28 |
| Abdominal PainGastrointestinal disorders | 8/27 | 5/28 |
| VomitingGastrointestinal disorders | 8/27 | 3/28 |
| PyrexiaGeneral disorders | 8/27 | 6/28 |
| RashSkin and subcutaneous tissue disorders | 7/27 | 7/28 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/27 | 7/28 |
| Age, Categorical(Participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 20 | 36 |
| >=65 years | 11 | 8 | 19 |
| Age, Continuous(years) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Mean | 58.4 ± 12.32 | 58.2 ± 10.65 | 58.3 ± 11.39 |
| Sex: Female, Male(Participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Female | 16 | 10 | 26 |
| Male | 11 | 18 | 29 |
| Region of Enrollment(participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Belgium | 6 | 3 | 9 |
| United States | 10 | 9 | 19 |
| United Kingdom | 3 | 2 | 5 |
| Italy | 1 | 1 | 2 |
| France | 3 | 4 | 7 |
| Spain | 4 | 9 | 13 |
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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