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NCT00227591 · ClinicalTrials.gov registry record · Phase 2

Lenalidomide and Prednisone in Treating Patients With Myelofibrosis

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

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT00227591: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00227591 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00227591, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.

Primary Outcome

Response was evaluated for Anemia and Spleen: Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess sple

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG prednisone
  • DRUG lenalidomide

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2005-12
Est. Completion 2010-12
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00227591 record still lists

NCT00227591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

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

NCT00227591 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00227591 about?

NCT00227591 is a clinical study titled "Lenalidomide and Prednisone in Treating Patients With Myelofibrosis". This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells...

What is the current status of trial NCT00227591?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2005-12. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00227591?

The interventions under investigation include: laboratory biomarker analysis (OTHER), prednisone (DRUG), lenalidomide (DRUG).

Who is sponsoring clinical trial NCT00227591?

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 NCT00227591's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 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 NCT00227591, the US trial registry maintained by the National Library of Medicine. NCT00227591 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.