Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
NCT ID: NCT02612311
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
603 participants
INTERVENTIONAL
2015-11-19
2023-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Ublituximab + Umbralisib
Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
Ublituximab
Ublituximab: IV infusion
TGR-1202
TGR-1202: Oral daily dose
Arm B: Obinutuzumab + Chlorambucil
Participants received Obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 15 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with Chlorambucil 0.5 milligram per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
Obinutuzumab
Obinutuzumab: IV infusion
Chlorambucil
Chlorambucil: Oral dose
Arm C: Ublituximab
Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.
Ublituximab
Ublituximab: IV infusion
Arm D: Umbralisib
Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
TGR-1202
TGR-1202: Oral daily dose
Interventions
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Obinutuzumab
Obinutuzumab: IV infusion
Ublituximab
Ublituximab: IV infusion
TGR-1202
TGR-1202: Oral daily dose
Chlorambucil
Chlorambucil: Oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria
* Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Concord, California, United States
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Duarte, California, United States
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Greenbrae, California, United States
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Pismo Beach, California, United States
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Pleasanton, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Bridgeport, Connecticut, United States
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New Haven, Connecticut, United States
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Stamford, Connecticut, United States
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Newark, Delaware, United States
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Boca Raton, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Ocala, Florida, United States
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Pensacola, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Albany, Georgia, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Maywood, Illinois, United States
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Niles, Illinois, United States
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Peoria, Illinois, United States
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Swansea, Illinois, United States
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Urbana, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Ames, Iowa, United States
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Cedar Rapids, Iowa, United States
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Kansas City, Kansas, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Jackson, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Morristown, New Jersey, United States
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Somerville, New Jersey, United States
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East Setauket, New York, United States
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Glens Falls, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Kinston, North Carolina, United States
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Raleigh, North Carolina, United States
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Washington, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Watertown, South Dakota, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Ogden, Utah, United States
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Blacksburg, Virginia, United States
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Charlottesville, Virginia, United States
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Fort Belvoir, Virginia, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Yakima, Washington, United States
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Milwaukee, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Ferrara, , Italy
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Milan, , Italy
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Rome, , Italy
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Torino, , Italy
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Chorzów, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Krasnozatonskiy, , Russia
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Moscow, , Russia
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Perm, , Russia
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Petrozavodsk, , Russia
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Rodionova, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Tula, , Russia
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Yaroslavl, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Cambridge, , United Kingdom
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Cumbria, , United Kingdom
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Dudley West, , United Kingdom
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London, , United Kingdom
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Northbrook, , United Kingdom
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Northumbria, , United Kingdom
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Norwich, , United Kingdom
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Peterborough, , United Kingdom
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Southampton, , United Kingdom
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St. James, , United Kingdom
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Sunderland, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-005758-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UTX-TGR-304
Identifier Type: -
Identifier Source: org_study_id