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NCT00089284 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL

A Phase 1 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00089284: Clinical Trial Phase 1 study, sponsored by Northwestern University.

NCT00089284 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00089284, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.

Primary Outcome

The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Commo

Interventions

  • DRUG Rituxan
  • DRUG motexafin gadolinium
  • DRUG 111Indium-Zevalin and 90Yttrium-Zevalin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2003-10-28
Est. Completion 2008-08-20
Phase Phase 1
Northwestern University

1,209 total trials

Why NCT00089284 stopped before completion

NCT00089284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 3 interventions - of which Rituxan is the first listed.

NCT00089284 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00089284 about?

NCT00089284 is a clinical study titled "Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL". Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan b...

What is the current status of trial NCT00089284?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2003-10-28. Estimated completion is 2008-08-20.

What interventions are being tested in trial NCT00089284?

The interventions under investigation include: Rituxan (DRUG), motexafin gadolinium (DRUG), 111Indium-Zevalin and 90Yttrium-Zevalin (DRUG).

Who is sponsoring clinical trial NCT00089284?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00089284's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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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Source: ClinicalTrials.gov NCT00089284, the US trial registry maintained by the National Library of Medicine. NCT00089284 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.