Clinical trial · Interventional
Chemotherapy for Participants With Lymphoma
An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
- interventionNames
- Drug: enzastaurin
- Drug: gemcitabine
- Drug: rituximab
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
- timeFrame
- First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year
- description
- PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available