A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only
NCT ID: NCT00451178
Last Updated: 2020-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2007-05-31
2013-01-31
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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R-CHOP and Enzastaurin
R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.
enzastaurin
1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
rituximab
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
cyclophosphamide
750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
doxorubicin
50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
vincristine
1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
prednisone
100 mg, oral, Days 1-5, six 21-day cycles
R-CHOP
R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.
rituximab
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
cyclophosphamide
750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
doxorubicin
50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
vincristine
1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
prednisone
100 mg, oral, Days 1-5, six 21-day cycles
Interventions
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enzastaurin
1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
rituximab
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
cyclophosphamide
750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
doxorubicin
50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
vincristine
1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
prednisone
100 mg, oral, Days 1-5, six 21-day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the participant is entered. Participants with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.
2. Have received no prior chemotherapy.
3. Have an International Prognostic Index (IPI) score ≥2 at time of original diagnosis.
4. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
5. Have adequate organ function as follows:
* Hepatic: total bilirubin ≤1.5 times the upper limit of normal (x ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 x ULN, (≤5 x ULN, if liver involvement).
* Renal: serum creatinine ≤1.5 x ULN.
* Adequate bone marrow reserve: platelets ≥75 x 10\^9 per Liter (L), absolute neutrophil count (ANC) ≥1.0 x 10\^9 per L, unless there is bone marrow involvement.
Exclusion Criteria
6. Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
7. Are receiving concurrent administration of any other systemic anticancer therapy.
8. Are pregnant or breastfeeding.
9. Are unable to swallow tablets.
10. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huntsville, Alabama, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beverly Hills, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenbrae, California, United States
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Palm Springs, California, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Saint Matthews, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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H6Q-MC-S028
Identifier Type: OTHER
Identifier Source: secondary_id
9824
Identifier Type: -
Identifier Source: org_study_id
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