Phase 2
Completed N=101
A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only
Source: ClinicalTrials.gov NCT00451178 ↗Enrolled (actual)
101
Serious AEs
53.0%
Results posted
Jul 2020
Primary outcomePrimary: Progression-Free Survival (PFS) Time — 36.2; 22.6 months
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) receiving first-line treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) Time |
36.2; 22.6 | — |
| SECONDARY Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate) |
51.8; 42.9; 83.9; 85.7 | — |
| SECONDARY Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) |
59; 49 | — |
| SECONDARY Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) |
44.6; 41.0 | — |
| SECONDARY Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan) |
26.8; 25.6; 53.6; 43.6 | — |
| SECONDARY Event-Free Survival (EFS) |
36.2; 22.6 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Duration of Complete Response (CR or CRu) |
NA; NA | — |
| SECONDARY Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin) |
56; 43; 50; 30; 35; 18 | — |
| SECONDARY PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS |
NA; 9.49; 27.96; 32.30; NA; NA | — |
Eligibility Criteria
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:
- 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
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.
Data sourced from ClinicalTrials.gov (NCT00451178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.