Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00012298 · ClinicalTrials.gov registry record · Phase 1
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT00012298: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00012298 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00012298, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.
Primary Outcome
This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.
Interventions
- BIOLOGICAL rituximab
- BIOLOGICAL filgrastim
- BIOLOGICAL yttrium Y 90 ibritumomab tiuxetan
- BIOLOGICAL indium In 111 ibritumomab tiuxetan
- BIOLOGICAL oprelvekin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2001-04 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
Why NCT00012298 stopped before completion
NCT00012298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 5 interventions - of which rituximab is the first listed.
NCT00012298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00012298 about?
NCT00012298 is a clinical study titled "Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma". Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and d...
What is the current status of trial NCT00012298?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2001-04. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00012298?
The interventions under investigation include: rituximab (BIOLOGICAL), filgrastim (BIOLOGICAL), yttrium Y 90 ibritumomab tiuxetan (BIOLOGICAL), indium In 111 ibritumomab tiuxetan (BIOLOGICAL), oprelvekin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00012298?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00012298's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT04966481 · 81 participants · Phase 3
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
- NCT05109429 · 81 participants · NA
Developing a Clinical Outcome Assessment for Opioid Craving
- NCT05112601 · 81 participants · Phase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
- NCT05305911 · 81 participants · Phase 2
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
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