Status:
COMPLETED
A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only
Lead Sponsor:
Eli Lilly and Company
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time measured in participants with intermediate and/or high risk for diffuse large B-cell lymphoma (DLBCL) receivin...
Eligibility Criteria
Inclusion
- Participants must:
- 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.
- Have received no prior chemotherapy.
- Have an International Prognostic Index (IPI) score ≥2 at time of original diagnosis.
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
- 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
- Participants must not:
- 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.
- Are receiving concurrent administration of any other systemic anticancer therapy.
- Are pregnant or breastfeeding.
- Are unable to swallow tablets.
- Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00451178
Start Date
May 1 2007
End Date
January 1 2013
Last Update
July 21 2020
Active Locations (25)
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1
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, 35805
2
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, 90211
3
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, 94904
4
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.
Palm Springs, California, United States, 92262