Clinical trial · Interventional
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision to discontinue development of entospletinib.
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate efficacy of entospletinib in participants with relapsed or refractory hematologic malignancies. Participants with the following relapsed or refractory hematologic malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-FL Indolent Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entospletinib MM | Drug | — | UNRESOLVED |
| Entospletinib SDD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- CLL, Entospletinib MM/SDD
- description
- Participants with CLL, receive original formulation (mono-mesylate \[MM\]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion \[SDD\]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Entospletinib MM
- Drug: Entospletinib SDD
- type
- EXPERIMENTAL
- label
- FL, Entospletinib MM/SDD
- description
- Participants with FL, receive original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib will continue until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Entospletinib MM
- Drug: Entospletinib SDD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization * For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol * Prior treatment for lymphoid malignancy requiring treatment for progressive disease * Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug * Karnofsky performance status of ≥ 60 * Life expectancy of at least 3 months Key Exclusion Criteria: * Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL participant is enrolling in the BCR previously treated cohort * Known active central nervous system or leptomeningeal lymphoma * Presence of known intermediate- or high-grade myelodysplastic syndrome * Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug * Ongoing liver injury * Ongoing or recent hepatic encephalopathy * Ongoing drug-induced pneumonitis * Ongoing inflammatory bowel disease * Ongoing alcohol or drug addiction * Pregnancy or breastfeeding * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy * Concurrent participation in an investigational drug trial with therapeutic intent NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
References
Publications (1)
- DERIVEDSharman J, Hawkins M, Kolibaba K, Boxer M, Klein L, Wu M, Hu J, Abella S, Yasenchak C. An open-label phase 2 trial of entospletinib (GS-9973), a selective spleen tyrosine kinase inhibitor, in chronic lymphocytic leukemia. Blood. 2015 Apr 9;125(15):2336-43. doi: 10.1182/blood-2014-08-595934. Epub 2015 Feb 18. PMID 25696919