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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S028 | Other Identifier | Eli Lilly and Company |
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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) receiving first-line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP and Enzastaurin | Experimental | R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies. |
|
| R-CHOP | Active Comparator | R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Time | PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy. | Randomization to measured PD or death from any cause (up to 55 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate) | CR, CRu, and PR were defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. PR is a 50% decrease in the sum of the products of diameters for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. The percentage of participants with complete response (CR/CRu) and objective response (Cr/CRu/PR)=(Number of participants whose best overall response was CR/CRu or Cr/CRu/PR)/(Number of participants treated)*100. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 35805 |
Study included chemotherapy, maintenance therapy (only R-CHOP and enzastaurin treatment arm) and follow-up post treatment for long-term efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | R-CHOP and Enzastaurin | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 milligrams (mg) Enzastaurin administered once daily (QD) as four 125-mg tablets, with 1125-mg loading dose [3 tablets, 3 times daily (TID)] on Day 2. R-CHOP included:
Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included participants (pts) who had complete response (CR), CR-unconfirmed (CRu) and/or were (positron emission tomography) PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Chemotherapy (Up To Six 21-Day Cycles) |
|
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| rituximab | Drug | 375 milligrams per square meter (mg/m^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles |
|
| cyclophosphamide | Drug | 750 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles |
|
| doxorubicin | Drug | 50 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles |
|
| vincristine | Drug | 1.4 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles |
|
| prednisone | Drug | 100 mg, oral, Days 1-5, six 21-day cycles |
|
| Baseline through long-term follow-up (up to 2 years post last dose) |
| Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) | PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. Percentage of participants alive progression-free at Year 2=(Number of participants alive progression free at Year 2)/(Number of participants assessed)*100. | Randomization to measured PD (up to Year 2) |
| Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) | The percentage of participants with a PET-negative scan=(Number of participants who had a PET-negative scan at Cycle 6)/(Number of participants who had a PET-positive scan at baseline)*100. | Cycle 6 (21 days/cycle) |
| Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan) | Lesion response was assessed according to International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. Percentage of participants with CR/CRu and/or PET-negative scan=(Number of participants with complete response and/or PET-negative scan at Cycle 6)/(Number of participants with a PET-positive scan at baseline)*100. | Cycle 6 (21 days/cycle) |
| Event-Free Survival (EFS) | EFS is the elapsed time from the date of randomization to the first date of objectively-determined PD, institution of a new anticancer treatment (other than maintenance therapy), or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date, who did not have objectively determined disease progression, and who were not treated with a new anticancer treatment, EFS was censored at the date of the last objectively determined disease-free assessment. | Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months) |
| Overall Survival (OS) | OS is the elapsed time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date or last date known to be alive, whichever was later. | Baseline to death from any cause (up to 55 months) |
| Duration of Complete Response (CR or CRu) | Duration of response (DOR) either CR or CRu: Elapsed time from date CR or CRu criteria met to first objectively-determined PD. For responding participants (pts) who died without PD and pts not known to have died as of data cut-off date, who did not have PD, DOR censored at date of last objective progression-free disease assessment. For responding pts who received subsequent systemic anticancer therapy (other than enzastaurin maintenance therapy) prior to PD, DOR was censored at date of last objective progression-free disease assessment prior to subsequent therapy. CR and CRu defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. | Time of response to PD (up to 55 months) |
| Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin) | Data presented are the number of participants who experienced at least 1 TEAE, Grade 3 or 4 Common Terminology Criteria for Adverse Events (CTCAE), serious adverse event (SAE), as well as the number of participants who discontinued due to an adverse event (AE) or SAE, who died on therapy, died within 30 days post treatment or within 60 days of first dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | First dose through 30 days post study treatment discontinuation (up to 56 months) |
| PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS | Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. | Randomization to measured PD or death from any cause (up to 55 months)] |
| 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 | 90211 | 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 | 94904 | 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. | Palm Springs | California | 92262 | 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. | Fort Myers | Florida | 33916 | 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. | Jacksonville | Florida | 32256 | 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. | Chicago | Illinois | 60631 | 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. | Indianapolis | Indiana | 46202 | 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. | South Bend | Indiana | 46601 | 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. | Saint Matthews | Kentucky | 40207 | 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. | Baltimore | Maryland | 21229 | 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. | Boston | Massachusetts | 02115 | 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. | Cincinnati | Ohio | 45242 | 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. | Columbus | Ohio | 43235 | 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. | Portland | Oregon | 97201 | 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. | Philadelphia | Pennsylvania | 19107 | 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. | Willow Grove | Pennsylvania | 19090 | 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. | Chattanooga | Tennessee | 37404 | 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. | Memphis | Tennessee | 38104 | 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. | Nashville | Tennessee | 37203 | 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. | Houston | Texas | 77030 | 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. | San Antonio | Texas | 78229 | 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. | Richmond | Virginia | 23230 | 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. | Everett | Washington | 98201 | 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 | 54601 | United States |
| FG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
| Received At Least 1 Dose Study Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| Prior to Maintenance Therapy |
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| Maintenance Therapy (up to 3 Years) |
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| Long-Term Follow-Up (Up to 2 Years) |
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Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen.
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| ID | Title | Description |
|---|---|---|
| BG000 | R-CHOP and Enzastaurin | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 mg Enzastaurin administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2. R-CHOP included:
Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included pts who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria. |
| BG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| International Prognostic Index (IPI) | IPI: tumor scoring system that divides population into risk groups by assigning 1 point for presence of each variable [age >60; lymphoma Stage III (involvement of lymph node regions, both sides of diaphragm) or Stage IV (disseminated involvement ≥1 extra-lymphatic site with or without associated lymph node involvement); >1 extranodal site; elevated lactate dehydrogenase serum level; and Eastern Cooperative Oncology Group (ECOG) status >1: restrictive but ambulatory; range: 0 (fully active) to 4 (completely disabled)]. Range of IPI scores: 0 (low risk) to 5 (high risk). | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Time | PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. A total of 34 and 21 participants were censored in the R-CHOP/Enzastaurin and R-CHOP arms, respectively. | Posted | Median | 95% Confidence Interval | months | Randomization to measured PD or death from any cause (up to 55 months) |
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| Secondary | Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate) | CR, CRu, and PR were defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. PR is a 50% decrease in the sum of the products of diameters for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. The percentage of participants with complete response (CR/CRu) and objective response (Cr/CRu/PR)=(Number of participants whose best overall response was CR/CRu or Cr/CRu/PR)/(Number of participants treated)*100. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through long-term follow-up (up to 2 years post last dose) |
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| Secondary | Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) | PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. Percentage of participants alive progression-free at Year 2=(Number of participants alive progression free at Year 2)/(Number of participants assessed)*100. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to measured PD (up to Year 2) |
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| Secondary | Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) | The percentage of participants with a PET-negative scan=(Number of participants who had a PET-negative scan at Cycle 6)/(Number of participants who had a PET-positive scan at baseline)*100. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had a PET-positive scan at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 6 (21 days/cycle) |
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| Secondary | Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan) | Lesion response was assessed according to International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. Percentage of participants with CR/CRu and/or PET-negative scan=(Number of participants with complete response and/or PET-negative scan at Cycle 6)/(Number of participants with a PET-positive scan at baseline)*100. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen, who had a PET-positive scan at baseline. | Posted | Number | percentage of participants | Cycle 6 (21 days/cycle) |
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| Secondary | Event-Free Survival (EFS) | EFS is the elapsed time from the date of randomization to the first date of objectively-determined PD, institution of a new anticancer treatment (other than maintenance therapy), or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date, who did not have objectively determined disease progression, and who were not treated with a new anticancer treatment, EFS was censored at the date of the last objectively determined disease-free assessment. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. A total of 31 and 20 participants were censored in the R-CHOP/Enzastaurin and R-CHOP arms, respectively. | Posted | Median | 95% Confidence Interval | months | Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months) |
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| Secondary | Overall Survival (OS) | OS is the elapsed time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date or last date known to be alive, whichever was later. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who had at least 1 post-baseline efficacy measurement. A total of 42 and 28 participants were censored in the R-CHOP/Enzastaurin and R-CHOP arms, respectively. | Posted | Median | 95% Confidence Interval | months | Baseline to death from any cause (up to 55 months) |
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| Secondary | Duration of Complete Response (CR or CRu) | Duration of response (DOR) either CR or CRu: Elapsed time from date CR or CRu criteria met to first objectively-determined PD. For responding participants (pts) who died without PD and pts not known to have died as of data cut-off date, who did not have PD, DOR censored at date of last objective progression-free disease assessment. For responding pts who received subsequent systemic anticancer therapy (other than enzastaurin maintenance therapy) prior to PD, DOR was censored at date of last objective progression-free disease assessment prior to subsequent therapy. CR and CRu defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen who achieved CR or CRu. A total of 22 and 9 participants were censored in the R-CHOP/Enzastaurin and R-CHOP arms, respectively. | Posted | Median | 95% Confidence Interval | days | Time of response to PD (up to 55 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin) | Data presented are the number of participants who experienced at least 1 TEAE, Grade 3 or 4 Common Terminology Criteria for Adverse Events (CTCAE), serious adverse event (SAE), as well as the number of participants who discontinued due to an adverse event (AE) or SAE, who died on therapy, died within 30 days post treatment or within 60 days of first dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Safety Population: Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen. | Posted | Count of Participants | Participants | No | First dose through 30 days post study treatment discontinuation (up to 56 months) |
| ||||||||||||||||||||||||||||||
| Secondary | PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS | Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. | Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen, who had at least 1 post-baseline efficacy measurement and had a reported value for the biomarker measure of interest. | Posted | Median | 95% Confidence Interval | months | Randomization to measured PD or death from any cause (up to 55 months)] |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R-CHOP and Enzastaurin | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP and 500 mg Enzastaurin administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2. R-CHOP included:
Only this arm eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included pts who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if pts had PR and/or were PET-positive/equivocal, or pts who discontinued therapy before 6 cycles otherwise met response criteria. | 35 | 57 | 56 | 57 | ||
| EG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
| 18 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 16.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | 16.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 16.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | 16.0 | Systematic Assessment |
| |
| Pain | General disorders | 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 16.0 | Systematic Assessment |
| |
| Alpha haemolytic streptococcal infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 16.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 16.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 16.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | 16.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 16.0 | Systematic Assessment |
| |
| Chills | General disorders | 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 16.0 | Systematic Assessment |
| |
| Oedema | General disorders | 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 16.0 | Systematic Assessment |
| |
| Pain | General disorders | 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 16.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 16.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 16.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Physician Decision |
|
| Death |
|
| PD |
|
| Continuing Maintenance |
|
| Male |
|
| African |
|
| Hispanic |
|
| East Asian |
|
| West Asian |
|
| OG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
| R-CHOP |
Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
|
|
| OG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
| OG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
| OG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
| OG001 | R-CHOP | Chemotherapy for up to 6 cycles, 21 days/cycle, with R-CHOP. For each cycle, R-CHOP therapy included:
|
|
|
| OG001 | High Biomarker Expression (R-CHOP) | Participants with high relative biomarker expression levels who were randomized to R-CHOP chemotherapy, up to 6 cycles, 21 days/cycle. For each cycle, R-CHOP included:
|
| OG002 | Low Biomarker Expression (R-CHOP and Enzastaurin) | Participants with low relative biomarker expression levels who were randomized to R-CHOP and Enzastaurin chemotherapy, up to 6 cycles, 21 days/cycle. For each cycle, R-CHOP included:
Enzastaurin: 500 mg administered QD as four 125-mg tablets, with 1125-mg loading dose (3 tablets, TID) on Day 2. Only R-CHOP and Enzastaurin participants eligible for maintenance therapy (500 mg enzastaurin, QD up to 3 years). This included participants who had CR, CRu and/or were PET-negative. Maintenance therapy allowed, at investigator's discretion, if participants had PR and/or were PET-positive/equivocal, or participants who discontinued therapy before 6 cycles otherwise met response criteria. |
| OG003 | Low Biomarker Expression (R-CHOP) | Participants with low relative biomarker expression levels who were randomized to R-CHOP chemotherapy, up to 6 cycles, 21 days/cycle. For each cycle, R-CHOP included:
|
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|
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