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NCT00096018 · ClinicalTrials.gov registry record · Phase 1

Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target

NCT00096018: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT00096018 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00096018, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

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. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.

Primary Outcome

Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)

Interventions

  • DRUG fludarabine phosphate
  • DRUG thalidomide

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2002-05
Est. Completion 2012-05
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

What the finished NCT00096018 record still lists

NCT00096018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which fludarabine phosphate is the first listed.

NCT00096018 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00096018 about?

NCT00096018 is a clinical study titled "Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed 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. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with...

What is the current status of trial NCT00096018?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2002-05. Estimated completion is 2012-05.

What interventions are being tested in trial NCT00096018?

The interventions under investigation include: fludarabine phosphate (DRUG), thalidomide (DRUG).

Who is sponsoring clinical trial NCT00096018?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00096018's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 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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Source: ClinicalTrials.gov NCT00096018, the US trial registry maintained by the National Library of Medicine. NCT00096018 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.