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NCT01796470 · REGISTRY CONDITION SEARCH

Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2020-06-02

This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

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outcome · POSTED

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

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outcome · POSTED

Maximum Tolerated Dose Level

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Time to Response (TTR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Key Inclusion Criteria: * Diagnosis of B-cell indolent non-Hodgkin lymphoma (iNHL),diffuse large B-cell lymphoma (DLBCL),mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (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®; GS-1101); individuals with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol * Prior treatment for lymphoid malignancy * Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug * 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 NHL (ie, Richter transformation) * Known active central nervous system or leptomeningeal lymphoma * Presence of known intermediate- or high-grade myelodysplastic syndrome * Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors * 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Entospletinib plus idelalisib at one of 4 dose combinations (400 mg/100 mg; 600 mg/100 mg; 800 mg/100 mg; 800 mg/150 mg). After discontinuation of entospletinib+idelalisib combination therapy, and following a washout period, participants may continue to receive entospletinib 400 mg monotherapy.
    intervention Names
    1. Drug: Entospletinib
    2. Drug: Idelalisib
    label
    Entospletinib + idelalisib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Entospletinib + idelalisib
    description
    Entospletinib tablets administered orally twice daily
    name
    Entospletinib
    other Names
    1. GS-9973
    type
    DRUG
  2. arm Group Labels
    1. Entospletinib + idelalisib
    description
    Idelalisib tablets administered orally twice daily
    name
    Idelalisib
    other Names
    1. GS-1101
    2. GS 1101
    3. Cal-101
    4. Cal 101
    5. Zydelig®
    type
    DRUG
Study design
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
66
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Objective Response Rate (ORR)
    time Frame
    Start of treatment to end of treatment (Up to 18 months)
secondary Outcomes
  1. description
    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.
    measure
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events
    time Frame
    First dose date up to the last dose date plus 30 days (maximum duration: 19 months)
  2. description
    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.
    measure
    Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
    time Frame
    First dose date up to the last dose date plus 30 days (maximum: 18 months)
  3. description
    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.
    measure
    Maximum Tolerated Dose Level
    time Frame
    First dose (entospelinib + idelalisib) date up to 6 months
  4. description
    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.
    measure
    Progression-free Survival (PFS)
    time Frame
    Start of treatment to end of treatment (Up to 18 months)
  5. description
    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.
    measure
    Duration of Response (DOR)
    time Frame
    Start of treatment to end of treatment (Up to 18 months)
  6. description
    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.
    measure
    Time to Response (TTR)
    time Frame
    Start of treatment to end of treatment (Up to 18 months)
Full study description
brief Summary
This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).
Source references
references
  1. citation
    Barr PM, Saylors GB, Spurgeon SE, Cheson BD, Greenwald DR, O'Brien SM, Liem AK, Mclntyre RE, Joshi A, Abella-Dominicis E, Hawkins MJ, Reddy A, Di Paolo J, Lee H, He J, Hu J, Dreiling LK, Friedberg JW. Phase 2 study of idelalisib and entospletinib: pneumonitis limits combination therapy in relapsed refractory CLL and NHL. Blood. 2016 May 19;127(20):2411-5. doi: 10.1182/blood-2015-12-683516. Epub 2016 Mar 11.
    pmid
    26968534
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice