A Phase 2 interventional study of enzastaurin and rituximab in Lymphoma, sponsored by Eli Lilly and Company. Completed at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 101 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must:
Have adequate organ function as follows:
Exclusion Criteria:
Participants must not:
R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.
Drug: enzastaurin · Drug: rituximab · Drug: cyclophosphamide · Drug: doxorubicin · Drug: vincristine · Drug: prednisone
R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.
Drug: rituximab · Drug: cyclophosphamide · Drug: doxorubicin · Drug: vincristine · Drug: prednisone
1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
Also known as: LY317615
375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
100 mg, oral, Days 1-5, six 21-day cycles
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.
Time frame: Randomization to measured PD or death from any cause (up to 55 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: Randomization to measured PD or death from any cause (up to 55 months)]
| Milestone | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Started | 58 | 43 |
| Received at least 1 dose study treatment | 57 | 43 |
| Completed | 40 | 26 |
| Not completed | 18 | 17 |
| Withdrew: Adverse event | 6 | 6 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Death | 4 | 3 |
| Withdrew: Progressive disease (pd) | 1 | 2 |
| Milestone | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Started | 40 | 0 |
| Completed | 36 | 0 |
| Not completed | 4 | 0 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Pd | 2 | 0 |
| Milestone | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Started | 36 | 0 |
| Completed | 6 | 0 |
| Not completed | 30 | 0 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Pd | 10 | 0 |
| Withdrew: Continuing maintenance | 9 | 0 |
| Milestone | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Started | 6 | 26 |
| Completed | 0 | 0 |
| Not completed | 6 | 26 |
| Withdrew: Continuing follow-up | 6 | 26 |
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.
| months | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Progression-Free Survival (PFS) Time | 36.2 (20.2 to NA) | 22.6 (8.9 to NA) |
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.
| percentage of participants | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Complete Response | 51.8 (38.0 to 65.3) | 42.9 (27.7 to 59.0) |
| Objective Response | 83.9 (71.7 to 92.4) | 85.7 (71.5 to 94.6) |
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.
| percentage of participants | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) | 59 (45 to 73) | 49 (32 to 66) |
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.
| percentage of participants | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) | 44.6 (31.3 to 58.5) | 41.0 (25.6 to 57.9) |
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.
| percentage of participants | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| CR/CRu and PET-Negative Post-Baseline | 26.8 | 25.6 |
| CR/CRu or PET-Negative Post-Baseline | 53.6 | 43.6 |
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.
| months | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Event-Free Survival (EFS) | 36.2 (14.6 to NA) | 22.6 (8.9 to NA) |
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.
| months | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (32.3 to NA) |
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.
| days | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Duration of Complete Response (CR or CRu) | NA (813 to NA) | NA (1053 to NA) |
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.
| Participants | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| At Least 1 TEAE | 56 | 43 |
| At Least 1 Grade 3/4 CTCAE | 50 | 30 |
| At Least 1 SAE | 35 | 18 |
| Discontinued due to AE | 10 | 6 |
| Discontinued due to SAE | 4 | 3 |
| Died on Therapy (all causes) | 5 | 3 |
| Died within 30 days post treatment discontinuation | 6 | 3 |
| Died within 60 days of first dose | 3 | 2 |
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.
| months | High Biomarker Expression (R-CHOP and Enzastaurin) | High Biomarker Expression (R-CHOP) | Low Biomarker Expression (R-CHOP and Enzastaurin) | Low Biomarker Expression (R-CHOP) |
|---|---|---|---|---|
| Marker: EIF4EBP1 Cytoplasm | NA (12.9 to NA) | 9.49 (8.2 to NA) | 27.96 (10.9 to NA) | 32.30 (2.4 to 32.3) |
| Marker: EIF4EBP1 Nucleus | — | NA (NA to NA) | NA (12.9 to NA) | 10.55 (4.5 to NA) |
| Marker: EIF4E Cytoplasm | NA (4.3 to NA) | 21.42 (2.4 to NA) | 27.96 (17.1 to NA) | NA (4.5 to NA) |
| Marker: EIF4E Nucleus | — | 4.50 (NA to NA) | NA (12.9 to NA) | 32.30 (8.9 to NA) |
| Marker: HDAC2 Nucleus | 27.96 (4.3 to NA) | 10.55 (8.2 to 32.3) | NA (12.9 to NA) | NA (2.4 to NA) |
| Marker: PCREB Nucleus | 24.10 (4.3 to NA) | 10.55 (2.4 to NA) | NA (12.9 to NA) | NA (NA to NA) |
| Marker: PEIF3746 Cytoplasm | 27.96 (8.2 to NA) | 20.90 (4.5 to NA) | NA (4.3 to NA) | NA (2.4 to NA) |
| Marker: PEIF3746 Nucleus | NA (8.2 to NA) | NA (4.5 to NA) | NA (4.3 to NA) | 32.30 (2.4 to 32.3) |
| Marker: PEIFS209 Cytoplasm | NA (4.3 to NA) | 9.20 (2.4 to NA) | 27.96 (8.2 to NA) | NA (10.5 to NA) |
| Marker: PEIFS65 Nucleus | NA (4.3 to NA) | NA (8.9 to NA) | 27.96 (20.2 to NA) | 32.30 (2.4 to NA) |
| Marker: PEIFT70 Cytoplasm | NA (8.2 to NA) | NA (8.9 to NA) | 27.96 (10.9 to NA) | 10.55 (2.4 to NA) |
| Marker: PEIFT70 Nucleus | NA (4.3 to NA) | 32.30 (2.4 to NA) | 27.96 (10.9 to NA) | NA (10.5 to NA) |
| Marker: P GSK3B Cytoplasm | 27.96 (10.9 to NA) | 21.42 (2.4 to NA) | NA (8.2 to NA) | 9.49 (4.5 to NA) |
| Marker: PKCb2 Cytoplasm | 27.96 (4.3 to NA) | 10.55 (2.4 to NA) | NA (10.9 to NA) | 20.90 (8.2 to 32.3) |
| Marker: PS6 Cytoplasm | NA (10.9 to NA) | 10.02 (4.5 to NA) | 16.57 (12.9 to 20.2) | NA (2.4 to NA) |
| Marker: PTEN Cytoplasm | 27.96 (8.2 to NA) | 21.42 (4.5 to NA) | NA (4.3 to NA) | 9.49 (2.4 to NA) |
| Marker: PTEN Nucleus | 27.96 (10.9 to NA) | 6.34 (4.5 to 8.2) | NA (8.2 to NA) | 32.30 (8.9 to NA) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R-CHOP and Enzastaurin | — | 35/57 (61.4%) | 56/57 (98.2%) |
| R-CHOP | — | 18/43 (41.9%) | 43/43 (100%) |
| Event | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 9/57 | 3/43 |
| PyrexiaGeneral disorders | 3/57 | 4/43 |
| SepsisInfections and infestations | 2/57 | 4/43 |
| PneumoniaInfections and infestations | 5/57 | 2/43 |
| AnaemiaBlood and lymphatic system disorders | 4/57 | 1/43 |
| NeutropeniaBlood and lymphatic system disorders | 2/57 | 3/43 |
| HypotensionVascular disorders | 3/57 | 0/43 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/57 | 2/43 |
| Atrial fibrillationCardiac disorders | 1/57 | 2/43 |
| Urinary tract infectionInfections and infestations | 2/57 | 2/43 |
| Event | R-CHOP and Enzastaurin | R-CHOP |
|---|---|---|
| FatigueGeneral disorders | 30/57 | 29/43 |
| NeutropeniaBlood and lymphatic system disorders | 33/57 | 26/43 |
| NauseaGastrointestinal disorders | 29/57 | 19/43 |
| DiarrhoeaGastrointestinal disorders | 27/57 | 15/43 |
| AlopeciaSkin and subcutaneous tissue disorders | 26/57 | 17/43 |
| ThrombocytopeniaBlood and lymphatic system disorders | 16/57 | 18/43 |
| ConstipationGastrointestinal disorders | 22/57 | 18/43 |
| AnaemiaBlood and lymphatic system disorders | 22/57 | 14/43 |
| StomatitisGastrointestinal disorders | 19/57 | 10/43 |
| LeukopeniaBlood and lymphatic system disorders | 16/57 | 14/43 |
Randomized participants who received at least 1 dose of enzastaurin or any drug in the R-CHOP regimen.
| Age, Continuous(years) | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|
| Mean | 63.5 ± 13.55 | 63.3 ± 12.36 | 63.4 ± 12.99 |
| Sex: Female, Male(Participants) | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|
| Female | 23 | 21 | 44 |
| Male | 34 | 22 | 56 |
| Race/Ethnicity, Customized(Participants) | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|
| Caucasian | 46 | 39 | 85 |
| African | 6 | 3 | 9 |
| Hispanic | 3 | 1 | 4 |
| East Asian | 2 | 0 | 2 |
| West Asian | 0 | 0 | 0 |
| Region of Enrollment(Participants) | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|
| United States | 57 | 43 | 100 |
| International Prognostic Index (IPI)(units on a scale) | R-CHOP and Enzastaurin | R-CHOP | Total |
|---|---|---|---|
| Mean | 2.88 ± 0.803 | 2.84 ± 0.843 | 2.86 ± 0.815 |
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