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NCT00648739 · ClinicalTrials.gov registry record · Phase 1
Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00648739: Clinical Trial Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT00648739 is a Phase 1 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648739, a Phase 1 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.
Primary Outcome
The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurr
Interventions
- DRUG Samalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-06-19 |
| Est. Completion | 2010-12-14 |
| Phase | Phase 1 |
Why NCT00648739 stopped before completion
NCT00648739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Samalizumab is the first listed.
NCT00648739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648739 about?
NCT00648739 is a clinical study titled "Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM". The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express ...
What is the current status of trial NCT00648739?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2008-06-19. Estimated completion is 2010-12-14.
What interventions are being tested in trial NCT00648739?
The interventions under investigation include: Samalizumab (DRUG).
Who is sponsoring clinical trial NCT00648739?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00648739's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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