Trial · NCT01882803
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
NCT01882803, Phase 2, Completed, SecuraBio; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma. Trials, record NCT01882803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01882803
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
- NCT number
- NCT01882803
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- SecuraBio
- Conditions
- Indolent Non-Hodgkin Lymphoma
- Interventions
- Duvelisib
- First posted
- 2013-06-20
- Last updated
- 2023-09-07
- Other registries' IDs
- eudract:2013-004008-20
- Results first posted
- 2018-11-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Every 8-16 weeks while on treatment with duvelisib for up to 72 months | ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Every 2-8 weeks for up to 73 months | An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Duration of Response (DOR) | Every 8-16 weeks for up to 72 months | DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. |
| Secondary | Progression-free Survival (PFS) | Every 8-16 weeks for up to 72 months | PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. |
| Secondary | Overall Survival (OS) | Every 16 weeks for up to 72 months | OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. |
| Secondary | Plasma Concentration of Duvelisib and IPI-656 | Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit) | The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL). |
| Secondary | Time to Response (TTR) | First dose to first documentation of complete or partial response (up to 6 months) | TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee \[IRC\]) according to the revised IWG Response Criteria for Malignant Lymphoma. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Every 8-16 weeks while on treatment with duvelisib for up to 72 months | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Every 2-8 weeks for up to 73 months | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Every 8-16 weeks for up to 72 months | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Every 8-16 weeks for up to 72 months | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Every 16 weeks for up to 72 months | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | months | MEDIAN |
| SECONDARY | Plasma Concentration of Duvelisib and IPI-656 | Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit) | Pharmacokinetics (PK) Set: all participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample. | ng/mL | MEDIAN |
| SECONDARY | Time to Response (TTR) | First dose to first documentation of complete or partial response (up to 6 months) | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib and who were considered responders (CR or PR) per IRC. | month | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Duvelisib | 59.7 | 95% Confidence Interval 50.7 to 68.2 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Duvelisib | 128 | Participants | ||
| Duration of Response (DOR) | Duvelisib | 10.16 | 95% Confidence Interval 8.78 to 13.61 | months | |
| Progression-free Survival (PFS) | Duvelisib | 9.57 | 95% Confidence Interval 8.35 to 11.70 | months | |
| Overall Survival (OS) | Duvelisib | 28.96 | 95% Confidence Interval 21.37 to 37.02 | months | |
| Plasma Concentration of Duvelisib and IPI-656 | Duvelisib | C1D15 Predose | 414 | Full Range 19 to 4590 | ng/mL |
| Plasma Concentration of Duvelisib and IPI-656 | IPI-656 | C1D15 Predose | 648 | Full Range 116 to 6010 | ng/mL |
| Plasma Concentration of Duvelisib and IPI-656 | Duvelisib | C1D15 1 hour post dose | 1175 | Full Range 206 to 6820 | ng/mL |
| Plasma Concentration of Duvelisib and IPI-656 | IPI-656 | C1D15 1 hour post dose | 641 | Full Range 160 to 5920 | ng/mL |
| Plasma Concentration of Duvelisib and IPI-656 | Duvelisib | C1D15 4 hours post dose | 852 | Full Range 233 to 5170 | ng/mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duvelisib | 129 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Duvelisib | 129 | |
| Overall Study | COMPLETED | Duvelisib | 0 | |
| Overall Study | NOT COMPLETED | Duvelisib | 129 |
Source ClinicalTrials.gov
Adverse events147
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Duvelisib | 37 | 129 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Duvelisib | 25 | 129 | |
| other | Anaemia | Blood and lymphatic system disorders | Duvelisib | 36 | 129 | |
| other | Diarrhoea | Gastrointestinal disorders | Duvelisib | 63 | 129 | |
| other | Nausea | Gastrointestinal disorders | Duvelisib | 38 | 129 | |
| other | Vomiting | Gastrointestinal disorders | Duvelisib | 22 | 129 | |
| other | Abdominal pain | Gastrointestinal disorders | Duvelisib | 20 | 129 | |
| other | Constipation | Gastrointestinal disorders | Duvelisib | 15 | 129 | |
| other | Dry mouth | Gastrointestinal disorders | Duvelisib | 9 | 129 | |
| other | Stomatitis | Gastrointestinal disorders | Duvelisib | 9 | 129 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duvelisib | 68 | 129 |
| Total, other adverse events | Duvelisib | 122 | 129 |
| Total, serious adverse events | Duvelisib | 83 | 129 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30742566 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01882803
GET https://conductscience.org/api/trials/v1/NCT01882803/events?page=2