Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00118209 · ClinicalTrials.gov registry record · Phase 3
Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 524
- Enrollment target
NCT00118209: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00118209 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 524 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118209, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 524 participants
- Enrollment target
Study Summary
This randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
Primary Outcome
Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse\> * ≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.\> * Appearance of any new lesion during or after completion of therapy.\> * PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy pro
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG doxorubicin
- DRUG vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2005-05 |
| Est. Completion | 2021-11-15 |
| Phase | Phase 3 |
What the finished NCT00118209 record still lists
NCT00118209 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT00118209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118209 about?
NCT00118209 is a clinical study titled "Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma". This randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in differe...
What is the current status of trial NCT00118209?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 524 participants. The study started on 2005-05. Estimated completion is 2021-11-15.
What interventions are being tested in trial NCT00118209?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), doxorubicin (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT00118209?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00118209's enrollment target sits among peer trials
524 716th of 2000 higher than 1,285 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04580134 · 524 participants · Phase 4
CLOZAPINE Response in Biotype-1
- NCT07158814 · 524 participants · Phase 4
Safety of RSV Preventive Monoclonal Antibody
- NCT04769492 · 525 participants · NA
#ChopViolence/#ChopHIV
- NCT05260047 · 525 participants · NA
Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia