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NCT00410163 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
A Phase 2 study of Leukaemia, Lymphocytic, Chronic, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 2
- Study locations
NCT00410163: Completed Phase 2 study of Leukaemia, Lymphocytic, Chronic, sponsored by GlaxoSmithKline.
NCT00410163 is a Phase 2 study of Leukaemia, Lymphocytic, Chronic that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410163, a Phase 2 study of Leukaemia, Lymphocytic, Chronic, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 2
- Study locations
Study Summary
To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
Primary Outcome
Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as "complete responders". As per NCI-WG, CR requires all of the following criteria for a period of \>=2 months: absence of lymphadenopathy (all lymph nodes \<1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes \<=4.0\*10\^9/l
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Ofatumumab 500mg
- DRUG Ofatumumab 1000mg
Study Locations (2)
Texas
- GSK Investigational Site - Houston
Devon
- GSK Investigational Site - Plymouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00410163 record still lists
NCT00410163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Leukaemia, Lymphocytic, Chronic appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00410163 reports a single indexed study location in Texas, Devon.
Frequently Asked Questions
What is clinical trial NCT00410163 about?
NCT00410163 is a clinical study titled "Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients". To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
What is the current status of trial NCT00410163?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2007-01. Estimated completion is 2013-05.
What conditions does trial NCT00410163 study?
This clinical trial studies the following conditions: Leukaemia, Lymphocytic, Chronic.
What interventions are being tested in trial NCT00410163?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Ofatumumab 500mg (DRUG), Ofatumumab 1000mg (DRUG).
Who is sponsoring clinical trial NCT00410163?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00410163 being conducted?
This trial has 2 study locations across Texas, Devon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukaemia, Lymphocytic, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00410163's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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