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NCT01133275 · ClinicalTrials.gov registry record · Phase 2

Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS

A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT01133275 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 28 participants.

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The verdict

NCT01133275, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS). Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. As it is being used in this study it is considered an investigational use. An "investigational use" is a use that is being tested and is not approved by the FDA. Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS. "Study drug" refers to the combination of lenalidomide and prednisone.

Interventions

  • DRUG Lenalidomide
  • DRUG Prednisone

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2010-04-28
Est. Completion 2019-11-21
Phase Phase 2

What the Registry Record Tells You About NCT01133275

The ClinicalTrials.gov registry entry for NCT01133275 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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

NCT01133275 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01133275 about?

NCT01133275 is a clinical study titled "Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS". The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS). Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in t...

What is the current status of trial NCT01133275?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2010-04-28. Estimated completion is 2019-11-21.

What interventions are being tested in trial NCT01133275?

The interventions under investigation include: Lenalidomide (DRUG), Prednisone (DRUG).

Who is sponsoring clinical trial NCT01133275?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.