Trial · NCT01799889
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
NCT01799889, Phase 2, Terminated, Gilead Sciences; results first posted 2020-09-23
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ConductScience Library. Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies. Trials, record NCT01799889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01799889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
- NCT number
- NCT01799889
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 326 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Non-FL Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma
- Interventions
- Entospletinib MM, Entospletinib SDD
- First posted
- 2013-02-27
- Last updated
- 2020-11-19
- Results first posted
- 2020-09-23
- Limitations and caveats
- Study was terminated prematurely due to sponsor's decision to discontinue development of entospletinib.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | Week 16 | PFS rate was assessed by Independent Review Committee (IRC) and defined per standardized criteria (2007 Cheson criteria) (for NHL) and International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal immunoglobulin M (IgM) concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using Kaplan-Meier (KM) estimates. |
| Primary | PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | Week 24 | PFS rate was assessed by IRC and defined per standardized criteria (2007 Cheson criteria) (for NHL) and IWCLL criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria (2007 Cheson criteria) as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal IgM concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using KM estimates. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | A treatment-emergent Adverse Event (AE) was defined as an AE that occurs in the period from the first dose of study treatment to 30 days after the last dose of study treatment or leads to discontinuation of study treatment. Participants were assessed for AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. |
| Secondary | Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | Hematology toxicity at any time postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ANC = absolute neutrophil count; Hb = hemoglobin; WBC = white blood cells |
| Secondary | Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | Serum chemistry toxicity at anytime postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase |
| Secondary | Objective Response Rate (ORR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From first dose date until first occurrence of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years) | ORR: percentage of participants with complete response (CR) or partial response (PR) (or very good PR \[VGPR\] or minor response \[MR\] for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters of all index lesions, no new lesions; VGPR: \>90% decrease from baseline (DFB) in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no increase from baseline (IFB) in SPD of lesions, no new lesions. Per IWCLL, CR: lymphocytes (Ly) \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, absolute neutrophil count (ANC) \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, hemoglobin (Hb) \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL. |
| Secondary | Duration of Response (DOR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From the date of first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to disease progression or death from any cause (up to approximately 7 years) | DOR was defined as the interval from first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to earlier of first documentation of definitive disease progression or death from any cause. Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of longest diameters of all index lesions, no new lesions; VGPR: \>90% DFB in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, Hb \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC\>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL. Disease progression: as defined in Outcome measure 1. DOR was analyzed using KM estimates. |
| Secondary | Time to Response (TTR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years) | TTR was defined as the interval from the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥ 50% reduction in SPD of the longest diameters of all index lesions, no new lesions; VGPR: \>90% DFB in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, Hb \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | Week 16 | The Full Analysis Set included all enrolled participants who took at least one dose of study drug with treatment group designated according to the planned treatment. Only participants with CLL after BCR target therapy (including CLL non-Richters, and CLL Richters participants), SDD, MCL, and DLBCL were analyzed for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | Week 24 | Participants in the full analysis set were analyzed. Only participants with CLL (including CLL, prior BCR inhibitor naive participants), FL, and non-FL iNHL were analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher | First dose date up to the last dose date plus 30 days (maximum: 78.4 months) | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From first dose date until first occurrence of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years) | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From the date of first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to disease progression or death from any cause (up to approximately 7 years) | Participants in the Full Analysis Set with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Time to Response (TTR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL) | From the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years) | Participants in the Full Analysis Set with available data were analyzed. | months | MEAN |
Source ClinicalTrials.gov
Results by group872
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | DLBCL: Entospletinib MM/SDD | 3.6 | 95% Confidence Interval 0.3 to 15.2 | percentage of participants | |
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | MCL: Entospletinib MM/SDD | 63.9 | 95% Confidence Interval 45 to 77.8 | percentage of participants | |
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD | 64 | 95% Confidence Interval 43.2 to 78.9 | percentage of participants | |
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD | 100 | 95% Confidence Interval 100 to 100 | percentage of participants | |
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD | 20 | 95% Confidence Interval 0.8 to 58.2 | percentage of participants | |
| Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16 | CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD | 50 | 95% Confidence Interval 0.6 to 91 | percentage of participants | |
| PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | CLL: Entospletinib MM/SDD | 66.9 | 95% Confidence Interval 48 to 80.2 | percentage of participants | |
| PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | FL: Entospletinib MM/SDD | 51.5 | 95% Confidence Interval 32.8 to 67.4 | percentage of participants | |
| PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | Non-FL iNHL: Entospletinib MM/SDD | 63.5 | 95% Confidence Interval 45.3 to 77.1 | percentage of participants | |
| PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24 | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg | 64.2 | 95% Confidence Interval 33.4 to 83.6 | percentage of participants |
1 to 10 of 872Source ClinicalTrials.gov
See all 872 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CLL: Entospletinib MM/SDD | 41 | |
| Overall Study | STARTED | FL: Entospletinib MM/SDD | 41 | |
| Overall Study | STARTED | DLBCL: Entospletinib MM/SDD | 44 | |
| Overall Study | STARTED | MCL: Entospletinib MM/SDD | 39 | |
| Overall Study | STARTED | Non-FL iNHL: Entospletinib MM/SDD | 49 | |
| Overall Study | STARTED | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg | 20 | |
| Overall Study | STARTED | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg | 21 | |
| Overall Study | STARTED | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg | 20 | |
| Overall Study | STARTED | CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD | 33 | |
| Overall Study | STARTED | CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD | 8 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events5,736
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 | CLL: Entospletinib MM/SDD | 12 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | FL: Entospletinib MM/SDD | 7 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | DLBCL: Entospletinib MM/SDD | 11 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | MCL: Entospletinib MM/SDD | 6 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Non-FL iNHL: Entospletinib MM/SDD | 9 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg | 6 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg | 7 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg | 3 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD | 13 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD | 1 | 8 |
1 to 10 of 5,736Source ClinicalTrials.gov
See all 5,736 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CLL: Entospletinib MM/SDD | 4 | 41 |
| Total, all-cause mortality | FL: Entospletinib MM/SDD | 3 | 41 |
| Total, all-cause mortality | DLBCL: Entospletinib MM/SDD | 13 | 43 |
| Total, all-cause mortality | MCL: Entospletinib MM/SDD | 6 | 39 |
| Total, all-cause mortality | Non-FL iNHL: Entospletinib MM/SDD | 5 | 49 |
| Total, all-cause mortality | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg | 0 | 19 |
| Total, all-cause mortality | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg | 1 | 21 |
| Total, all-cause mortality | CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg | 1 | 20 |
| Total, all-cause mortality | CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD | 3 | 33 |
| Total, all-cause mortality | CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD | 1 | 8 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25696919 | 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.
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