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NCT00098670 · ClinicalTrials.gov registry record · Phase 2

Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
102
Enrollment target

NCT00098670: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00098670 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00098670, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.

Primary Outcome

A complete response, as defined by the National Cancer Institute Working Group (NCIWG): \- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy

Interventions

  • BIOLOGICAL rituximab
  • DRUG fludarabine phosphate
  • BIOLOGICAL alemtuzumab

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2004-10
Est. Completion 2011-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00098670 record still lists

NCT00098670 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).

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

NCT00098670 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00098670 about?

NCT00098670 is a clinical study titled "Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia". This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of can...

What is the current status of trial NCT00098670?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2004-10. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00098670?

The interventions under investigation include: rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), alemtuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00098670?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00098670's enrollment target sits among peer trials

102 668th of 2000 higher than 1,329 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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Source: ClinicalTrials.gov NCT00098670, the US trial registry maintained by the National Library of Medicine. NCT00098670 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.