Phase 2
Completed N=68
Chemotherapy for Participants With Lymphoma
Source: ClinicalTrials.gov NCT00436280 ↗Enrolled (actual)
68
Serious AEs
44.1%
Results posted
Aug 2020
Primary outcomePrimary: Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment — 16.4 percentage of participants
Summary
The primary purpose of this study is to help answer the following research questions:
* To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
* To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
* To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
* To look at the level of enzastaurin in the body and how long it remains.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment |
16.4 | — |
| SECONDARY Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response) |
50; 52.50 | — |
| SECONDARY Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment |
12.1; 8.7 | — |
| SECONDARY Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years |
52.3; 29.9; 20.9 | — |
| SECONDARY Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years |
15.0; 10.3; 8.6 | — |
| SECONDARY Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin) |
7.8; 4.7 | — |
| SECONDARY PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin) |
3.6; 6.1 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites] |
2750 | — |
| SECONDARY PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte |
44100 | — |
| SECONDARY Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years |
69.2; 52.7; 52.7 | — |
| SECONDARY Duration of Tumor Response (DOR) |
23.4 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent lymphoma
- Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
- Measurable disease (lymph node greater than 1.5 cm)
- Adequate organ function
- Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)
Exclusion Criteria
- Prior Allogeneic transplantation
- More than 2 prior anticancer treatment regimens
- Pregnant or breastfeeding
- Human-immunodeficiency-virus (HIV)associated lymphomas
- Brain metastases
Data sourced from ClinicalTrials.gov (NCT00436280). 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.