Clinical trial · Interventional
Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)
Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP
NCT00450385CI-TRIAL-00028236R-CHOPterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator Decision due to insufficient accrual.
Summary
Brief summary (as posted)
The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP
- description
- Patients will receive R-CHOP for 6 to 8 cycles: * Rituximab 375 mg/m2 on day 1 * Cyclophosphamide 750 mg/m2 IV on day 1 * Doxorubicin 50 mg/m2 on day 1 * Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 * Prednisone 100 mg orally days 1-5, repeated every 21 days.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Prednisone
- Drug: Vincristine
Primary outcomes (3)
- measure
- Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.
- timeFrame
- 30 months
- description
- The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World Health Organization Classification, stages II-IV or limited stage I disease that is bulky (more than 10 cm) or with International Prognostic Index (IPI) score \> 1. * 2\. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A short course (\< 2 weeks) of corticosteroids is allowed. * 3\. Adequate paraffin-embedded tumor specimen must be available for gene expression analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is deemed inadequate, the subject can be retroactively screen failed, as this does not change the treatment regimen). * 4\. Baseline measurements and evaluation must be obtained within 4 weeks before first treatment. * 5\. Age \>18 years. * 6\. Eastern Cooperative Oncology Group (ECOG) performance status 0-3. * 7\. Adequate organ function: * White Blood Cells count (WBC) \>2500/µL * Absolute Neutrophil Count (ANC) \> 1000/µL (unless due to disease in marrow) * platelet count \>100,000/µL (unless due to disease in marrow) * creatinine \< 2.0 mg/dL, * bilirubin \< 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by lymphoma) * Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) \<3 x upper limit of normal. * 8\. Female patients must not be pregnant or breast feeding. * 9\. Women of childbearing potential and men must be strongly advised to use an accepted and effective method of contraception. * 10\. Patients must have left ventricular ejection fraction of \>45%. * 11\. Provision of written informed consent. Exclusion Criteria: * 1\. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least two years previously; and; the patient continue to be free of evidence of recurrence. * 2\. Patients with HIV infection as these patients are managed on dedicated protocols. * 3\. Patients with active central nervous system (CNS) lymphoma.
References
Publications (0)
Data not yet available
No reference posted for this study.