CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
lenalidomide +2 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • Diagnosed with myelofibrosis with myeloid metaplasia (MMM), agnogenic myeloid metaplasia, post-polycythemic myeloid metaplasia, or post-thrombocythemic myeloid metaplasia, confirmed by central pathology review
  • ECOG performance status 0, 1, or 2
  • Hemoglobin ≤10 g/dL or transfusion-dependent
  • Lenalidomide-naïve (never previously treated with lenalidomide)
Key exclusion· 4
  • Known hypersensitivity to thalidomide or lenalidomide
  • Positive status for HIV or infectious hepatitis type A, B, or C
  • Any other active malignancy
  • Any condition placing the patient at unacceptable risk or confounding data interpretation, in the physician's opinion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00227591
NCT00227591Phase 2Completed

A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia

National Cancer Institute (NCI)·interventional·Posted Sep 28, 2005·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating lenalidomide, prednisone, and 1 other intervention for Essential Thrombocythemia and 2 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

lenalidomidedrug

Given orally (PO)

prednisonedrug

Given PO

laboratory biomarker analysisother

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