Trial · NCT01796470
Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies
NCT01796470, Phase 2, Terminated, Gilead Sciences; results first posted 2020-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies. Trials, record NCT01796470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01796470
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies
- NCT number
- NCT01796470
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Indolent Non-Hodgkin's Lymphoma
- Interventions
- Entospletinib, Idelalisib
- First posted
- 2013-02-21
- Last updated
- 2020-06-02
- Results first posted
- 2020-06-02
- Limitations and caveats
- As a result of the early termination of the trial for safety, the efficacy endpoints were not evaluable due to insufficient treatment exposure.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Start of treatment to end of treatment (Up to 18 months) | ORR assessed by the Independent Review Committee (IRC), was based on the International Working Group Revised Response Criteria (Cheson, 2012) and investigator's response, defined as the percentage of participants achieving a complete response (CR) or partial response (PR) (or very good partial response \[VGPR\] or minor response \[MR\] for participants with LPL/WM). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal immunoglobulin M (IgM) concentration by serum protein electrophoresis (SPEP) respectively. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to the last dose date plus 30 days (maximum duration: 19 months) | A treatment-emergent Adverse Event (AE) was defined as any AE with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drugs or an AE leading to premature discontinuation of study drug. An AE is any untoward medical occurrence in a clinical investigation where participants administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to the last dose date plus 30 days (maximum: 18 months) | A treatment-emergent laboratory (Hematology, Serum Chemistry and Urinalysis) abnormality was defined as an abnormality that, compared to baseline, worsens by ≥ 1 grade in the period from the first dose of study drug. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 0 = none, Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening or disabling. If baseline data are missing, then any graded abnormality (i.e., an abnormality that is Grade ≥ 1 in severity) will be considered treatment-emergent. The percentage of participants in each worst postbaseline grade is reported. |
| Secondary | Maximum Tolerated Dose Level | First dose (entospelinib + idelalisib) date up to 6 months | Maximum tolerated dose (MTD) is defined as the highest dose level that was consistently well tolerated without dose limiting toxicity (DLT) for the majority of participants time on treatment (ie,\> 50%) as determined by the investigator for each participant. DLTs are defined as Grade 4 hematological toxicities persisting for ≥ 14 days or Grade ≥ 3 toxicities of other types. |
| Secondary | Progression-free Survival (PFS) | Start of treatment to end of treatment (Up to 18 months) | PFS was defined as the interval from the first dose of study drug to the earlier of the first documentation of definitive disease progression or death from any cause. |
| Secondary | Duration of Response (DOR) | Start of treatment to end of treatment (Up to 18 months) | DOR was defined as the interval from the first-time response (CR or PR \[or VGPR or MR for participants with LPL/WM\]) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause.CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal IgM concentration by SPEP respectively. |
| Secondary | Time to Response (TTR) | Start of treatment to end of treatment (Up to 18 months) | TTR was defined as the interval from the first dose of entospletinib/idelalisib to the time response (CR or PR \[or VGPR or MR for participants with LPL/WM\]) is first achieved. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. VGPR and MR were defined as ≥ 90% and ≥ 25% but \< 50% decrease from baseline in serum monoclonal IgM concentration by SPEP respectively. |
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 | Objective Response Rate (ORR) | Start of treatment to end of treatment (Up to 18 months) | The study was terminated due to safety measures. Complete data was not collected for any participant. | ||
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to the last dose date plus 30 days (maximum duration: 19 months) | The Safety Analysis Set comprised all participants who received ≥ 1 dose of study drug (entospletinib or idelalisib). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to the last dose date plus 30 days (maximum: 18 months) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Maximum Tolerated Dose Level | First dose (entospelinib + idelalisib) date up to 6 months | The study was terminated due to safety measures. Complete data was not collected for any participant. | ||
| SECONDARY | Progression-free Survival (PFS) | Start of treatment to end of treatment (Up to 18 months) | The study was terminated due to safety measures. Complete data was not collected for any participant. | ||
| SECONDARY | Duration of Response (DOR) | Start of treatment to end of treatment (Up to 18 months) | The study was terminated due to safety measures. Complete data was not collected for any participant. | ||
| SECONDARY | Time to Response (TTR) | Start of treatment to end of treatment (Up to 18 months) | The study was terminated due to safety measures. Complete data was not collected for any participant. |
Source ClinicalTrials.gov
Results by group385
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Entospletinib + Idelalisib CLL | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Entospletinib + Idelalisib iNHL: FL | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Entospletinib + Idelalisib DLBCL | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Entospletinib + Idelalisib MCL | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Entospletinib + Idelalisib iNHL: Others | 100 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Entospletinib + Idelalisib CLL | Neutrophils Count Decreased (Grade 1) | 17.1 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Entospletinib + Idelalisib iNHL: FL | Neutrophils Count Decreased (Grade 1) | 21.4 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Entospletinib + Idelalisib DLBCL | Neutrophils Count Decreased (Grade 1) | 0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Entospletinib + Idelalisib MCL | Neutrophils Count Decreased (Grade 1) | 66.7 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Entospletinib + Idelalisib iNHL: Others | Neutrophils Count Decreased (Grade 1) | 25.0 | percentage of participants |
1 to 10 of 385Source ClinicalTrials.gov
See all 385 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entospletinib + Idelalisib CLL | 35 | |
| Overall Study | STARTED | Entospletinib + Idelalisib iNHL: FL | 14 | |
| Overall Study | STARTED | Entospletinib + Idelalisib DLBCL | 6 | |
| Overall Study | STARTED | Entospletinib + Idelalisib MCL | 3 | |
| Overall Study | STARTED | Entospletinib + Idelalisib iNHL: Others | 8 | |
| Overall Study | Entospletinib Monotherapy | Entospletinib + Idelalisib CLL | 4 | |
| Overall Study | Entospletinib Monotherapy | Entospletinib + Idelalisib iNHL: FL | 4 | |
| Overall Study | Entospletinib Monotherapy | Entospletinib + Idelalisib DLBCL | 0 | |
| Overall Study | Entospletinib Monotherapy | Entospletinib + Idelalisib MCL | 0 | |
| Overall Study | Entospletinib Monotherapy | Entospletinib + Idelalisib iNHL: Others | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events845
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 | Anaemia | Blood and lymphatic system disorders | Entospletinib + Idelalisib CLL | 5 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Entospletinib + Idelalisib iNHL: FL | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Entospletinib + Idelalisib DLBCL | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Entospletinib + Idelalisib MCL | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Entospletinib + Idelalisib iNHL: Others | 0 | 8 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Entospletinib + Idelalisib CLL | 2 | 35 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Entospletinib + Idelalisib iNHL: FL | 0 | 14 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Entospletinib + Idelalisib DLBCL | 0 | 6 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Entospletinib + Idelalisib MCL | 0 | 3 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Entospletinib + Idelalisib iNHL: Others | 0 | 8 |
1 to 10 of 845Source ClinicalTrials.gov
See all 845 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Entospletinib + Idelalisib CLL | 3 | 35 |
| Total, all-cause mortality | Entospletinib + Idelalisib iNHL: FL | 1 | 14 |
| Total, all-cause mortality | Entospletinib + Idelalisib DLBCL | 2 | 6 |
| Total, all-cause mortality | Entospletinib + Idelalisib MCL | 2 | 3 |
| Total, all-cause mortality | Entospletinib + Idelalisib iNHL: Others | 2 | 8 |
| Total, other adverse events | Entospletinib + Idelalisib CLL | 34 | 35 |
| Total, other adverse events | Entospletinib + Idelalisib iNHL: FL | 14 | 14 |
| Total, other adverse events | Entospletinib + Idelalisib DLBCL | 6 | 6 |
| Total, other adverse events | Entospletinib + Idelalisib MCL | 3 | 3 |
| Total, other adverse events | Entospletinib + Idelalisib iNHL: Others | 8 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26968534 | 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/NCT01796470
GET https://conductscience.org/api/trials/v1/NCT01796470/results?page=2