Clinical trial · Interventional
A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status
NCT00333008CI-TRIAL-00000457unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxil | Drug | Doxorubicin | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
- measure
- Efficacy: tumor evaluations every three (q 3) cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 60 years old and older or 18 years old and older with significant/potential cardiac morbidity * Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score. * Previously untreated * New York Heart Association (NYHA) classification of Class III or better * Baseline ejection fraction (EF) \> 25% * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 * Unless attributable to NHL: absolute neutrophil count (ANC) \> 1500/uL, platelets \> 100,000/uL; hemoglobin \> 9.0 g/dl * Bilirubin \< 1.5 mg/dL (unless related to lymphoma) * Hepatic: transaminases \< 2.5 x upper limit of normal (ULN) (unless related to lymphoma) * Creatinine \< 2.5 mg/dl (unless related to lymphoma) Exclusion Criteria: * No HIV+ individuals * No primary central nervous system (CNS) lymphoma * No pregnant or lactating women * No serious active infection * History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
References
Publications (0)
Data not yet available
No reference posted for this study.