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NCT00983619 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
NCT00983619: Completed Phase 1 study, sponsored by MedImmune.
NCT00983619 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 136 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983619, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
Primary Outcome
Optimal biologic dose (OBD) was defined as the dose lower than the maximum tolerated dose (MTD), used for dose expansion. The MTD is defined as the highest dose at which less than equal to (\<=) 1 out of 6 participants experience a dose limiting toxicities (DLT) from the time of first administration of MEDI-551 through the first 28-day cycle.
Interventions
- DRUG Rituximab
- DRUG MEDI-551
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2010-04-16 |
| Est. Completion | 2019-03-21 |
| Phase | Phase 1 |
What the finished NCT00983619 record still lists
NCT00983619 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00983619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983619 about?
NCT00983619 is a clinical study titled "A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies". The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
What is the current status of trial NCT00983619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2010-04-16. Estimated completion is 2019-03-21.
What interventions are being tested in trial NCT00983619?
The interventions under investigation include: Rituximab (DRUG), MEDI-551 (DRUG).
Who is sponsoring clinical trial NCT00983619?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00983619's enrollment target sits among peer trials
136 422nd of 2000 higher than 1,576 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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