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NCT00438880 · ClinicalTrials.gov registry record · Phase 1
Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00438880: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00438880 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00438880, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.
Primary Outcome
Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following: * Absolute neutrophil counts or platelet counts below 10\*10\^9/L for 14 days * Absolute neu
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Rituximab
- PROCEDURE Radionuclide Imaging
- DRUG Agatolimod Sodium
- RADIATION Indium In-111 Ibritumomab Tiuxetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT00438880 record still lists
NCT00438880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00438880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00438880 about?
NCT00438880 is a clinical study titled "Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma". RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others fin...
What is the current status of trial NCT00438880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2004-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00438880?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Rituximab (BIOLOGICAL), Radionuclide Imaging (PROCEDURE), Agatolimod Sodium (DRUG), Indium In-111 Ibritumomab Tiuxetan (RADIATION).
Who is sponsoring clinical trial NCT00438880?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00438880's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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
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