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NCT00086775 · ClinicalTrials.gov registry record · Phase 2

Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

A Phase 2 study, sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase

NCT00086775: Completed Phase 2 study, sponsored by Bayer.

NCT00086775 is a Phase 2 study that has completed, run by Bayer. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00086775, a Phase 2 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase

Study Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.

Interventions

  • BIOLOGICAL rituximab
  • DRUG fludarabine phosphate
  • BIOLOGICAL alemtuzumab

Trial Details

FieldValue
Start Date 2003-07
Est. Completion 2009-10
Phase Phase 2
Bayer

591 total trials

What the finished NCT00086775 record still lists

NCT00086775 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

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

NCT00086775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00086775 about?

NCT00086775 is a clinical study titled "Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia". RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them witho...

What is the current status of trial NCT00086775?

This trial is currently completed. It is a Phase 2 study. The study started on 2003-07. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00086775?

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

Who is sponsoring clinical trial NCT00086775?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00086775, the US trial registry maintained by the National Library of Medicine. NCT00086775 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.